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A Study to Assess the Efficacy and Safety of IMAB362 in Combination With Nab-Paclitaxel and Gemcitabine (Nab-P + GEM) as First Line Treatment in Subjects With Claudin 18.2 (CLDN18.2) Positive, Metastatic Pancreatic Adenocarcinoma

Primary Purpose

Pancreatic Cancer, Metastatic Pancreatic Cancer, Metastatic Pancreatic Adenocarcinoma

Status
Recruiting
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
zolbetuximab
nab-paclitaxel
gemcitabine
Sponsored by
Astellas Pharma Global Development, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pancreatic Cancer focused on measuring metastatic pancreatic cancer, IMAB362, nab-paclitaxel, gemcitabine, zolbetuximab, metastatic pancreatic adenocarcinoma, pancreatic cancer, CLDN 18.2

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • A female subject is eligible to participate if she is not pregnant or lactating and at least 1 of the following conditions applies:

    • Not a woman of childbearing potential (WOCBP) OR
    • WOCBP who agrees to follow the contraceptive guidance throughout the treatment period and for at least 6 months after the final study drug administration.
  • Female subject must agree not to breastfeed starting at screening and throughout the study period, and for 6 months after the final study drug administration.
  • Female subject must not donate ova starting at screening and throughout the study period, and for 6 months after the final study drug administration.
  • A male subject with female partner(s) of child-bearing potential must agree to use contraception during the treatment period and for at least 6 months after the final study drug administration.
  • A male subject must not donate sperm during the treatment period and for at least 6 months after the final study drug administration.
  • Male subject with a pregnant or breastfeeding partner(s) must agree to remain abstinent or use a condom for the duration of the pregnancy or time partner is breastfeeding throughout the study period and for 6 months after the final study drug administration.
  • Subject agrees not to participate in other interventional studies while receiving study drug in present study.
  • Subject has histologically or cytologically confirmed adenocarcinoma of pancreas.
  • Subjects must have metastatic pancreatic adenocarcinoma that has not been previously treated with chemotherapy.

    • Prior treatment with fluorouracil (5-FU) or GEM administered as a radiation sensitizer during and up to 4 weeks after radiation therapy is allowed
    • If a subject received adjuvant therapy, tumor recurrence or disease progression must have occurred at least 6 months after completing the last dose of the adjuvant therapy.
    • Subjects whose disease progressed on prior treatment with Nab-P and GEM are not eligible.
  • Subject has a measurable lesion(s) on at least 1 metastatic site based on RECIST 1.1 within 28 days prior to randomization. For subjects with only 1 measurable lesion and prior radiotherapy, the lesion must be outside the field of prior radiotherapy or must have documented progression following radiation therapy.
  • Subject's tumor sample has CLDN18.2 expression in ≥ 75% of tumor cells demonstrating moderate to strong membranous staining as determined by central immunohistochemistry (IHC) testing
  • Subject has Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  • Subject has predicted life expectancy ≥ 12 weeks.
  • Subject must meet all of the following criteria based on the laboratory tests that will be collected within 14 days prior to randomization. In case of multiple laboratory data within this period, the most recent data should be used.

    • Hemoglobin ≥ 9 g/dl (no transfusion within 14 days of start of study treatment)
    • Absolute neutrophil count ≥ 1.5 x 10^9/L
    • Platelets ≥ 100 x 10^9/L
    • Albumin ≥ 2.5 g/dL
    • Total bilirubin ≤ 1.5 x upper limit of normal (ULN)
    • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 x ULN without liver metastases (≤ 5 x ULN if liver metastases are present)
    • Estimated creatinine clearance ≥ 30 mL/min
    • Prothrombin time/international normalized ratio (INR) and partial thromboplastin time ≤ 1.5 x ULN (except for subjects receiving anticoagulation therapy)

Exclusion Criteria:

  • Subject has received other investigational treatment within 28 days prior to randomization.
  • Subject has received radiotherapy for metastatic pancreatic adenocarcinoma ≤ 14 days prior to randomization and has not recovered from any related toxicity.
  • Subject has received systemic immunosuppressive therapy, including systemic corticosteroids within 14 days prior to randomization. Subject using a physiologic replacement dose of hydrocortisone or its equivalent (defined as up to 30 mg per day of hydrocortisone or up to 10 mg per day of prednisone), receiving a single dose of systemic corticosteroids or receiving systemic corticosteroids as premedication for radiologic imaging contrast use are allowed.
  • Subject has prior severe allergic reaction or intolerance to known ingredients of zolbetuximab or other monoclonal antibody, including humanized or chimeric antibodies.
  • Subject has known immediate or delayed hypersensitivity, intolerance or contraindication to any component of study treatment.
  • Subject has a known history of a positive test for human immunodeficiency virus infection or known active hepatitis B (positive HBs antigen [Ag]) or hepatitis C infection. NOTE: Screening for these infections should be conducted per local requirements.

    1. For subjects who are negative for HBs Ag, but hepatitis B core antibody positive, a hepatitis B virus DNA test will be performed and if positive, the subject will be excluded.
    2. Subjects with positive hepatitis C serology but negative hepatitis C virus RNA test results are eligible.
    3. Subjects treated for hepatitis C with undetectable viral load results are eligible.
  • Subject has a history of interstitial pneumonia or pulmonary fibrosis.
  • Subject has pleural effusion or ascites ≥ Grade 3.
  • Subject has an active autoimmune disease that has required systemic treatment in the past 3 months prior to randomization.
  • Subject has active infection requiring systemic therapy that has not completely resolved per investigator judgment within 7 days prior to randomization.
  • Subject has significant cardiovascular disease, including:

    • Congestive heart failure (defined as New York Heart Association Class III or IV), myocardial infarction, unstable angina, coronary angioplasty, coronary stenting, coronary artery bypass graft, cerebrovascular accident or hypertensive crisis within 6 months prior to randomization;
    • History of clinically significant ventricular arrhythmias (i.e., sustained ventricular tachycardia, ventricular fibrillation or Torsades de Pointes);
    • QTc interval > 450 msec for male subjects; QTc interval > 470 msec for female subjects;
    • Cardiac arrhythmias requiring anti-arrhythmic medications (Subjects with rate controlled atrial fibrillation for > 1 month prior to randomization.)
  • Subject has a history of central nervous system metastases and/or carcinomatous meningitis from pancreatic adenocarcinoma.
  • Subject has known peripheral sensory neuropathy ≥ Grade 2 unless the absence of deep tendon reflexes is the sole neurological abnormality.
  • Subject has had a major surgical procedure ≤ 28 days prior to randomization.
  • Subject without complete recovery from a major surgical procedure ≤ 14 days prior to randomization.
  • Psychiatric illness or social situations that would preclude study compliance.
  • Subject has another malignancy for which treatment is required.
  • Subject has any concurrent disease, infection or co-morbid condition that interferes with the ability of the subject to participate in the study, which places the subject at undue risk or complicates the interpretation of data.

Sites / Locations

  • Cancer Treatment Centers of Phoenix
  • St. Joseph Heritage Medical GroupRecruiting
  • Hoag HospitalRecruiting
  • UCLA Hematology Oncology
  • TOI Clinical researchRecruiting
  • Midstate Medical CenterRecruiting
  • Lynn Cancer InstituteRecruiting
  • Baptist HealthRecruiting
  • Cancer Treatment Centers of Atlanta
  • University of Illinois at ChicagoRecruiting
  • The University of Chicago
  • Cancer Treatment Centers of America, Chicago
  • PMG Research of McFarland Clinic
  • Holden Comprehensive Cancer CenterRecruiting
  • University of Kansas Cancer Center
  • Norton Cancer Institute (NCI)Recruiting
  • Our Lady of the Lake
  • Ochsner Health System
  • David C Pratt Cancer Center
  • St Vincent's Frontier Cancer CenterRecruiting
  • Memorial Sloan Kettering Basking RidgeRecruiting
  • Memorial Sloan Kettering MonmouthRecruiting
  • Memorial Sloan Kettering BergenRecruiting
  • Roswell Park Cancer InstituteRecruiting
  • Memorial Sloan Kettering CommackRecruiting
  • Memorial Sloan Kettering WestchesterRecruiting
  • Northwell Health Cancer Institute
  • Memorial Sloan-Kettering Cancer CenterRecruiting
  • Memorial Sloan Kettering NassauRecruiting
  • Novant Health Presbyterian Medical CenterRecruiting
  • Novant HealthRecruiting
  • Mercy Clinic Oklahoma Communities, Inc
  • Cancer Treatment Centers of America at Eastern Regional Medical Center
  • Oncology Consultants PA
  • Houston Methodist HospitalRecruiting
  • Scott and White Memorial Hospital
  • Utah Cancer SpecialistsRecruiting
  • Inova Dwight and Martha ScharRecruiting
  • MultiCare Regional Cancer Center - Gig HarborRecruiting
  • Vista OncologyRecruiting
  • Virginia MasonRecruiting
  • Site AU61008Recruiting
  • Site AU61007Recruiting
  • Site AU61002
  • Site AU61005Recruiting
  • Site AU61006Recruiting
  • Site BR55003Recruiting
  • Site BR55002Recruiting
  • Site BR55008Recruiting
  • Site BR55004Recruiting
  • Site BR55001Recruiting
  • Site BR55006Recruiting
  • Site CN86001Recruiting
  • Site CN86008Recruiting
  • Site CN86014Recruiting
  • Site CN86026Recruiting
  • Site CN86009Recruiting
  • Site CN86004Recruiting
  • Site CN86020Recruiting
  • Site CN86016Recruiting
  • Site CN86012Recruiting
  • Site CN86002Recruiting
  • Site CN86005Recruiting
  • Site CN86011Recruiting
  • Site CN86025Recruiting
  • Site CN86024Recruiting
  • Site CN86023Recruiting
  • Site CN86006Recruiting
  • Site CN86013Recruiting
  • Site CN86019Recruiting
  • Site CN86017Recruiting
  • Site CN86007Recruiting
  • Site CN86022Recruiting
  • Site CN86003Recruiting
  • Site CN86018Recruiting
  • Site CN86010Recruiting
  • Site FR33008Recruiting
  • Site FR33010Recruiting
  • Site FR33004
  • Site FR33015Recruiting
  • Site FR33006Recruiting
  • Site FR33011Recruiting
  • Site FR33012Recruiting
  • Site FR33016Recruiting
  • Site FR33009Recruiting
  • Site FR33017Recruiting
  • Site FR33003Recruiting
  • Site FR33013Recruiting
  • Site FR33001Recruiting
  • Site FR33018Recruiting
  • Site FR33002Recruiting
  • Site FR33020Recruiting
  • Site FR33021Recruiting
  • Site FR33023Recruiting
  • Site FR33014Recruiting
  • Site FR33005Recruiting
  • Site FR33019Recruiting
  • Site FR33007Recruiting
  • Site IR35301Recruiting
  • Site IE35303Recruiting
  • Site IT39006Recruiting
  • Site IT39004Recruiting
  • Site IT39009Recruiting
  • Site IT39015Recruiting
  • Site IT39002Recruiting
  • Site IT39012Recruiting
  • Site IT39010Recruiting
  • Site IT39003Recruiting
  • Site IT39014Recruiting
  • Site IT39008Recruiting
  • Site JP81007Recruiting
  • Site JP81001Recruiting
  • Site JP81005Recruiting
  • Site JP81006Recruiting
  • Site JP81003Recruiting
  • Site JP81008Recruiting
  • Site JP81011Recruiting
  • Site JP81012Recruiting
  • Site JP81014Recruiting
  • Site JP81013Recruiting
  • Site JP81002Recruiting
  • Site JP81015Recruiting
  • Site JP81004Recruiting
  • Site JP81010
  • Site JP81009Recruiting
  • Site KR82005Recruiting
  • Site KR82008Recruiting
  • Site KR82010Recruiting
  • Site KR82009Recruiting
  • Site KR82011Recruiting
  • Site KR82001Recruiting
  • Site KR82003Recruiting
  • Site KR82004Recruiting
  • Site KR82007Recruiting
  • Site KR82002Recruiting
  • Site KR82006Recruiting
  • Site MX52004Recruiting
  • Site MX52003Recruiting
  • Site MX52005Recruiting
  • Site ES34004Recruiting
  • Site ES34001Recruiting
  • Site ES34011
  • Site ES34003Recruiting
  • Site ES34010Recruiting
  • Site ES34013Recruiting
  • Site ES34007Recruiting
  • Site ES34018Recruiting
  • Site ES34021Recruiting
  • Site ES34014Recruiting
  • Site ES34025Recruiting
  • Site ES34022Recruiting
  • Site ES34002Recruiting
  • Site ES34005Recruiting
  • Site ES34015
  • Site ES34016Recruiting
  • Site ES34006Recruiting
  • Site ES34009Recruiting
  • Site ES34012
  • Site ES34008Recruiting
  • Site ES34020Recruiting
  • Site ES34026Recruiting
  • Site ES34024Recruiting
  • Site ES34017Recruiting
  • Site TW88604Recruiting
  • Site TW88606
  • Site TW88607Recruiting
  • Site TW88608Recruiting
  • Site TW88602Recruiting
  • Site TW88603
  • Site TW88605
  • Site TW88601Recruiting
  • Site TW88609Recruiting
  • Site TR90004Recruiting
  • Site TR90006Recruiting
  • Site TR90003Recruiting
  • Site TR90002Recruiting
  • Site TR90005Recruiting
  • Site TR90001Recruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

zolbetuximab +nab-paclitaxel + gemcitabine

nab-paclitaxel + gemcitabine

Arm Description

Participants will be treated with zolbetuximab in combination with nab-paclitaxel and gemcitabine for the phase 1 portion of the study to establish the recommended dose of zolbetuximab for the phase 2 portion. In the phase 2 portion, the participants will be treated with zolbetuximab at dose determined by the phase 1 portion of the study in combination with nab-paclitaxel and gemcitabine. Participants will be treated on continuous cycles until they no longer derive clinical benefit in the judgment of the treating physician, have unacceptable toxicity, undergo hematopoietic stem cell transplantation (HSCT), or meet one of the discontinuation criteria; whichever occurs first.

Participants will be treated with nab-paclitaxel and gemcitabine. Participants will be treated on continuous cycles until they no longer derive clinical benefit in the judgment of the treating physician, have unacceptable toxicity, undergo hematopoietic stem cell transplantation (HSCT), or meet one of the discontinuation criteria; whichever occurs first.

Outcomes

Primary Outcome Measures

Dose Limiting Toxicities (DLT) - (safety lead in)
Incidence of dose limiting toxicities.
Overall Survival (OS)
OS is defined as the time from the date of randomization until the date of death from any cause.
Safety assessed by Adverse Events (AEs)
An AE is any untoward medical occurrence in a subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product.
Safety assessed by incidence of serious adverse events (SAE)
Adverse Event (AE) is considered "serious" if the investigator or sponsor view any of the following outcomes: Death, life-threatening, persistent or significant disability/incapacity, congenital anomaly or birth defect, hospitalization, or medically important event.
Safety assessed by incidence of treatment emergent adverse events (TEAE)
Treatment Emergent Adverse Event (TEAE) is defined as any AE which starts, or worsens, after the first dose of study drug through 30 days after the last dose of study drug.
Number of participants with laboratory value abnormalities and/or adverse events (AEs)
Number of participants with potentially clinically significant laboratory values.
Number of participants with vital sign abnormalities and /or adverse events (AEs)
Number of participants with potentially clinically significant vital sign values.
Number of participants with electrocardiograms (ECG) abnormalities and or adverse events
12-lead ECGs will be recorded. Prior to the ECG, participants should rest in supine position for 10 minutes. ECGs will be read and assessed locally.
Number of participants with Eastern Cooperative Oncology Group (ECOG) performance status abnormalities and or adverse events
Number of participants with potentially clinically significant ECOG performance status values. ECOG grades 0-5, where 0 = Fully active, able to carry on all pre-disease performance without restriction; 1 = Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work; 2 = Ambulatory and capable of all self-care but unable to carry out any work activities. Up and about more than 50% of waking hours; 3 = Capable of only limited self-care, confined to bed or chair more than 50% of waking hours; 4 = Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair and 5 = Dead.

Secondary Outcome Measures

Progression Free Survival (PFS)
PFS is defined as the time from the date of randomization until the date of radiological progressive disease (PD) per Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 by investigator evaluation or death from any cause, whichever is earliest.
Objective Response Rate (ORR)
ORR is defined as the proportion of participants who have a best overall response of Complete Response (CR) or Partial Response (PR) as assessed by investigator evaluation per RECIST 1.1.
Number of anti-drug antibody (ADA) Positive Participants
Immunogenicity will be measured by the number of participants that are ADA positive.
Disease Control Rate (DCR)
DCR is defined as the proportion of participants who have best overall response of stable disease, complete response (CR) or partial response (PR) as assessed by investigator evaluation per RECIST 1.1
Duration Of Response (DOR)
DOR is defined as the time from the date of the first response (CR/PR) until the date of progressive disease as assessed by investigator evaluation per RECIST 1.1 or date of death from any cause, whichever is earliest.
Change in CA (Cancer Antigen) 19-9
Change from baseline in serum CA19-9 will be assessed.
PK of zolbetuximab: Concentration Immediately Prior to Dosing (Ctrough)
Ctrough will be derived from the PK serum samples collected.
PK of Nab-P: Area Under the Concentration-time Curve from the Time of Dosing Extrapolated to Time Infinity (AUCinf)
AUCinf will be derived from the PK plasma samples collected.
PK of Nab-P: Area Under the Concentration-time Curve from the Time of Dosing Until the Last Measurable Concentration (AUClast)
AUClast will be derived from the PK plasma samples collected.
PK of Nab-P: Maximum Concentration (Cmax)
Cmax will be derived from the PK plasma samples collected.
PK of Nab-P: Time of Maximum Concentration (Tmax)
Tmax will be derived from the PK plasma samples collected.
PK of Nab-P: Terminal Elimination Half-life (T1/2)
T1/2 will be derived from the PK plasma samples collected.
PK of Nab-P: Clearance (CL)
CL will be derived from the PK plasma samples collected.
PK of Nab-P: Volume of Distribution During the Terminal Phase (Vz)
Vz will be derived from the PK plasma samples collected.
PK of gemcitabine: Area Under the Concentration-time Curve from the Time of Dosing Extrapolated to Time Infinity (AUCinf)
AUCinf will be derived from the PK plasma samples collected.
PK of gemcitabine: Area Under the Concentration-time Curve from the Time of Dosing Until the Last Measurable Concentration (AUClast)
AUClast will be derived from the PK plasma samples collected.
PK of gemcitabine: Maximum Concentration (Cmax)
Cmax will be derived from the PK plasma samples collected.
PK of gemcitabine: Time of Maximum Concentration (Tmax)
Tmax will be derived from the PK plasma samples collected.
PK of gemcitabine: Terminal Elimination Half-life (T1/2)
T1/2 will be derived from the PK plasma samples collected.
PK of gemcitabine: Clearance (CL)
CL will be derived from the PK plasma samples collected.
PK of gemcitabine: Volume of Distribution During the Terminal Phase (Vz)
Vz will be derived from the PK plasma samples collected.
Health Related Quality of Life (HRQoL) measured by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Core Questionnaire (EORTC-QLQ-C30)
The EORTC-QLQ-C30 is a 30-item cancer-specific instrument consisting of 5 functional scales (physical, role, emotional, social and cognitive), 9 symptom scales/items (fatigue, nausea/vomiting, general pain, dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties) and a global health status scale. Participants rate items on a four-point scale, with 1 as "not at all" and 4 as "very much." For functional scales, higher scores indicate better functioning, while for symptom scales/items, higher scores indicate worse symptoms.
Health Related Quality of Life (HRQoL) measured by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Pancreatic Cancer Module (EORTC-QLQ-PAN-26)
EORTC-QLQ-PAN26 is a 26-item questionnaire that evaluates pancreatic cancer-specific symptoms such as pain, dietary changes, jaundice, altered bowel habits, and emotional problems. Participants rate items on a four-point scale, with 1 as "not at all" and 4 as "very much." For symptom scales/items, higher scores indicate worse symptoms.
Health Related Quality of Life (HRQoL) measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L)
The EQ-5D-5L is a standardized instrument for use as a measure of health outcome consisting of 6 items that cover 5 main domains (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) and a general visual analog scale for health status. Each domain comprises 5 severity levels (no problems, slight problems, moderate problems, severe problems, extreme problems). The general visual analog scale records the respondent's self-rated health status on a vertical graduated (0 = the worst health a participant can imagine to 100 = the best health a participant can imagine) visual analogue scale. Responses to the 5 items will also be converted to a weighted health state index (utility score) based on values derived from general population samples.
Health Related Quality of Life (HRQoL) measured by the Patient Global Impression of Change (PGIC) scale
The PGIC is a single-item questionnaire that asks participants to provide the overall self-assessment of change in their disease on a 7-point scale ranging from "very much worse" to "very much better" as compared to the participant starting the study treatment. Only PGIC questions assessing pain and overall status will be collected.
Health Related Quality of Life (HRQoL) measured by the Patient Global Impression of Severity (PGIS) Scale
The PGIS is a single-item questionnaire that asks participants to provide the overall self-assessment of their disease severity on a 4-point scale for the past week, with 1 as "None" and 4 as "Severe". Only PGIS questions assessing pain and overall status will be collected.

Full Information

First Posted
January 23, 2019
Last Updated
October 6, 2023
Sponsor
Astellas Pharma Global Development, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT03816163
Brief Title
A Study to Assess the Efficacy and Safety of IMAB362 in Combination With Nab-Paclitaxel and Gemcitabine (Nab-P + GEM) as First Line Treatment in Subjects With Claudin 18.2 (CLDN18.2) Positive, Metastatic Pancreatic Adenocarcinoma
Official Title
A Phase 2, Open-Label, Randomized Study to Assess the Efficacy and Safety of Zolbetuximab (IMAB362) in Combination With Nab-Paclitaxel and Gemcitabine (Nab-P + GEM) as First Line Treatment in Subjects With Claudin 18.2 (CLDN18.2) Positive, Metastatic Pancreatic Adenocarcinoma
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 15, 2019 (Actual)
Primary Completion Date
September 30, 2024 (Anticipated)
Study Completion Date
April 30, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Astellas Pharma Global Development, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to confirm the recommended phase 2 dose (RP2D) of zolbetuximab in combination with Nab-P + GEM, determine overall survival and assess the safety and tolerability of the combination treatment. This study will also evaluate tumor markers and pharmacokinetics (PK) of zolbetuximab, Nab-P and GEM, and health-related quality of life (HRQoL).
Detailed Description
This study will have a safety lead in phase and a randomization phase.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Cancer, Metastatic Pancreatic Cancer, Metastatic Pancreatic Adenocarcinoma
Keywords
metastatic pancreatic cancer, IMAB362, nab-paclitaxel, gemcitabine, zolbetuximab, metastatic pancreatic adenocarcinoma, pancreatic cancer, CLDN 18.2

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
369 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
zolbetuximab +nab-paclitaxel + gemcitabine
Arm Type
Experimental
Arm Description
Participants will be treated with zolbetuximab in combination with nab-paclitaxel and gemcitabine for the phase 1 portion of the study to establish the recommended dose of zolbetuximab for the phase 2 portion. In the phase 2 portion, the participants will be treated with zolbetuximab at dose determined by the phase 1 portion of the study in combination with nab-paclitaxel and gemcitabine. Participants will be treated on continuous cycles until they no longer derive clinical benefit in the judgment of the treating physician, have unacceptable toxicity, undergo hematopoietic stem cell transplantation (HSCT), or meet one of the discontinuation criteria; whichever occurs first.
Arm Title
nab-paclitaxel + gemcitabine
Arm Type
Active Comparator
Arm Description
Participants will be treated with nab-paclitaxel and gemcitabine. Participants will be treated on continuous cycles until they no longer derive clinical benefit in the judgment of the treating physician, have unacceptable toxicity, undergo hematopoietic stem cell transplantation (HSCT), or meet one of the discontinuation criteria; whichever occurs first.
Intervention Type
Drug
Intervention Name(s)
zolbetuximab
Other Intervention Name(s)
IMAB362
Intervention Description
Administered as an intravenous infusion.
Intervention Type
Drug
Intervention Name(s)
nab-paclitaxel
Intervention Description
Administered as an intravenous infusion
Intervention Type
Drug
Intervention Name(s)
gemcitabine
Intervention Description
Administered as an intravenous infusion
Primary Outcome Measure Information:
Title
Dose Limiting Toxicities (DLT) - (safety lead in)
Description
Incidence of dose limiting toxicities.
Time Frame
Up to 28 days
Title
Overall Survival (OS)
Description
OS is defined as the time from the date of randomization until the date of death from any cause.
Time Frame
Up to 65 months
Title
Safety assessed by Adverse Events (AEs)
Description
An AE is any untoward medical occurrence in a subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product.
Time Frame
Up to 65 months
Title
Safety assessed by incidence of serious adverse events (SAE)
Description
Adverse Event (AE) is considered "serious" if the investigator or sponsor view any of the following outcomes: Death, life-threatening, persistent or significant disability/incapacity, congenital anomaly or birth defect, hospitalization, or medically important event.
Time Frame
Up to 65 months
Title
Safety assessed by incidence of treatment emergent adverse events (TEAE)
Description
Treatment Emergent Adverse Event (TEAE) is defined as any AE which starts, or worsens, after the first dose of study drug through 30 days after the last dose of study drug.
Time Frame
Up to 65 months
Title
Number of participants with laboratory value abnormalities and/or adverse events (AEs)
Description
Number of participants with potentially clinically significant laboratory values.
Time Frame
Up to 65 months
Title
Number of participants with vital sign abnormalities and /or adverse events (AEs)
Description
Number of participants with potentially clinically significant vital sign values.
Time Frame
Up to 65 months
Title
Number of participants with electrocardiograms (ECG) abnormalities and or adverse events
Description
12-lead ECGs will be recorded. Prior to the ECG, participants should rest in supine position for 10 minutes. ECGs will be read and assessed locally.
Time Frame
Up to 65 months
Title
Number of participants with Eastern Cooperative Oncology Group (ECOG) performance status abnormalities and or adverse events
Description
Number of participants with potentially clinically significant ECOG performance status values. ECOG grades 0-5, where 0 = Fully active, able to carry on all pre-disease performance without restriction; 1 = Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work; 2 = Ambulatory and capable of all self-care but unable to carry out any work activities. Up and about more than 50% of waking hours; 3 = Capable of only limited self-care, confined to bed or chair more than 50% of waking hours; 4 = Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair and 5 = Dead.
Time Frame
Up to 65 months
Secondary Outcome Measure Information:
Title
Progression Free Survival (PFS)
Description
PFS is defined as the time from the date of randomization until the date of radiological progressive disease (PD) per Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 by investigator evaluation or death from any cause, whichever is earliest.
Time Frame
Up to 65 months
Title
Objective Response Rate (ORR)
Description
ORR is defined as the proportion of participants who have a best overall response of Complete Response (CR) or Partial Response (PR) as assessed by investigator evaluation per RECIST 1.1.
Time Frame
Up to 65 months
Title
Number of anti-drug antibody (ADA) Positive Participants
Description
Immunogenicity will be measured by the number of participants that are ADA positive.
Time Frame
Up to 65 months
Title
Disease Control Rate (DCR)
Description
DCR is defined as the proportion of participants who have best overall response of stable disease, complete response (CR) or partial response (PR) as assessed by investigator evaluation per RECIST 1.1
Time Frame
Up to 65 months
Title
Duration Of Response (DOR)
Description
DOR is defined as the time from the date of the first response (CR/PR) until the date of progressive disease as assessed by investigator evaluation per RECIST 1.1 or date of death from any cause, whichever is earliest.
Time Frame
Up to 65 months
Title
Change in CA (Cancer Antigen) 19-9
Description
Change from baseline in serum CA19-9 will be assessed.
Time Frame
Baseline up to 65 months
Title
PK of zolbetuximab: Concentration Immediately Prior to Dosing (Ctrough)
Description
Ctrough will be derived from the PK serum samples collected.
Time Frame
Up to 65 months
Title
PK of Nab-P: Area Under the Concentration-time Curve from the Time of Dosing Extrapolated to Time Infinity (AUCinf)
Description
AUCinf will be derived from the PK plasma samples collected.
Time Frame
Up to 30 days
Title
PK of Nab-P: Area Under the Concentration-time Curve from the Time of Dosing Until the Last Measurable Concentration (AUClast)
Description
AUClast will be derived from the PK plasma samples collected.
Time Frame
Up to 30 days
Title
PK of Nab-P: Maximum Concentration (Cmax)
Description
Cmax will be derived from the PK plasma samples collected.
Time Frame
Up to 30 days
Title
PK of Nab-P: Time of Maximum Concentration (Tmax)
Description
Tmax will be derived from the PK plasma samples collected.
Time Frame
Up to 30 days
Title
PK of Nab-P: Terminal Elimination Half-life (T1/2)
Description
T1/2 will be derived from the PK plasma samples collected.
Time Frame
Up to 30 days
Title
PK of Nab-P: Clearance (CL)
Description
CL will be derived from the PK plasma samples collected.
Time Frame
Up to 30 days
Title
PK of Nab-P: Volume of Distribution During the Terminal Phase (Vz)
Description
Vz will be derived from the PK plasma samples collected.
Time Frame
Up to 30 days
Title
PK of gemcitabine: Area Under the Concentration-time Curve from the Time of Dosing Extrapolated to Time Infinity (AUCinf)
Description
AUCinf will be derived from the PK plasma samples collected.
Time Frame
Up to 30 days
Title
PK of gemcitabine: Area Under the Concentration-time Curve from the Time of Dosing Until the Last Measurable Concentration (AUClast)
Description
AUClast will be derived from the PK plasma samples collected.
Time Frame
Up to 30 days
Title
PK of gemcitabine: Maximum Concentration (Cmax)
Description
Cmax will be derived from the PK plasma samples collected.
Time Frame
Up to 30 days
Title
PK of gemcitabine: Time of Maximum Concentration (Tmax)
Description
Tmax will be derived from the PK plasma samples collected.
Time Frame
Up to 30 days
Title
PK of gemcitabine: Terminal Elimination Half-life (T1/2)
Description
T1/2 will be derived from the PK plasma samples collected.
Time Frame
Up to 30 days
Title
PK of gemcitabine: Clearance (CL)
Description
CL will be derived from the PK plasma samples collected.
Time Frame
Up to 30 days
Title
PK of gemcitabine: Volume of Distribution During the Terminal Phase (Vz)
Description
Vz will be derived from the PK plasma samples collected.
Time Frame
Up to 30 days
Title
Health Related Quality of Life (HRQoL) measured by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Core Questionnaire (EORTC-QLQ-C30)
Description
The EORTC-QLQ-C30 is a 30-item cancer-specific instrument consisting of 5 functional scales (physical, role, emotional, social and cognitive), 9 symptom scales/items (fatigue, nausea/vomiting, general pain, dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties) and a global health status scale. Participants rate items on a four-point scale, with 1 as "not at all" and 4 as "very much." For functional scales, higher scores indicate better functioning, while for symptom scales/items, higher scores indicate worse symptoms.
Time Frame
Up to 65 months
Title
Health Related Quality of Life (HRQoL) measured by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Pancreatic Cancer Module (EORTC-QLQ-PAN-26)
Description
EORTC-QLQ-PAN26 is a 26-item questionnaire that evaluates pancreatic cancer-specific symptoms such as pain, dietary changes, jaundice, altered bowel habits, and emotional problems. Participants rate items on a four-point scale, with 1 as "not at all" and 4 as "very much." For symptom scales/items, higher scores indicate worse symptoms.
Time Frame
Up to 65 months
Title
Health Related Quality of Life (HRQoL) measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L)
Description
The EQ-5D-5L is a standardized instrument for use as a measure of health outcome consisting of 6 items that cover 5 main domains (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) and a general visual analog scale for health status. Each domain comprises 5 severity levels (no problems, slight problems, moderate problems, severe problems, extreme problems). The general visual analog scale records the respondent's self-rated health status on a vertical graduated (0 = the worst health a participant can imagine to 100 = the best health a participant can imagine) visual analogue scale. Responses to the 5 items will also be converted to a weighted health state index (utility score) based on values derived from general population samples.
Time Frame
Up to 65 months
Title
Health Related Quality of Life (HRQoL) measured by the Patient Global Impression of Change (PGIC) scale
Description
The PGIC is a single-item questionnaire that asks participants to provide the overall self-assessment of change in their disease on a 7-point scale ranging from "very much worse" to "very much better" as compared to the participant starting the study treatment. Only PGIC questions assessing pain and overall status will be collected.
Time Frame
Up to 65 months
Title
Health Related Quality of Life (HRQoL) measured by the Patient Global Impression of Severity (PGIS) Scale
Description
The PGIS is a single-item questionnaire that asks participants to provide the overall self-assessment of their disease severity on a 4-point scale for the past week, with 1 as "None" and 4 as "Severe". Only PGIS questions assessing pain and overall status will be collected.
Time Frame
Up to 65 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: A female subject is eligible to participate if she is not pregnant or lactating and at least 1 of the following conditions applies: Not a woman of childbearing potential (WOCBP) OR WOCBP who agrees to follow the contraceptive guidance throughout the treatment period and for at least 6 months after the final study drug administration. Female subject must agree not to breastfeed starting at screening and throughout the study period, and for 6 months after the final study drug administration. Female subject must not donate ova starting at screening and throughout the study period, and for 6 months after the final study drug administration. A male subject with female partner(s) of child-bearing potential must agree to use contraception during the treatment period and for at least 6 months after the final study drug administration. A male subject must not donate sperm during the treatment period and for at least 6 months after the final study drug administration. Male subject with a pregnant or breastfeeding partner(s) must agree to remain abstinent or use a condom for the duration of the pregnancy or time partner is breastfeeding throughout the study period and for 6 months after the final study drug administration. Subject agrees not to participate in other interventional studies while receiving study drug in present study. Subject has histologically or cytologically confirmed adenocarcinoma of pancreas. Subjects must have metastatic pancreatic adenocarcinoma that has not been previously treated with chemotherapy. Prior treatment with fluorouracil (5-FU) or GEM administered as a radiation sensitizer during and up to 4 weeks after radiation therapy is allowed If a subject received adjuvant therapy, tumor recurrence or disease progression must have occurred at least 6 months after completing the last dose of the adjuvant therapy. Subjects whose disease progressed on prior treatment with Nab-P and GEM are not eligible. Subject has a measurable lesion(s) on at least 1 metastatic site based on RECIST 1.1 within 28 days prior to randomization. For subjects with only 1 measurable lesion and prior radiotherapy, the lesion must be outside the field of prior radiotherapy or must have documented progression following radiation therapy. Subject's tumor sample has CLDN18.2 expression in ≥ 75% of tumor cells demonstrating moderate to strong membranous staining as determined by central immunohistochemistry (IHC) testing Subject has Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. Subject has predicted life expectancy ≥ 12 weeks. Subject must meet all of the following criteria based on the laboratory tests that will be collected within 14 days prior to randomization. In case of multiple laboratory data within this period, the most recent data should be used. Hemoglobin ≥ 9 g/dl (no transfusion within 14 days of start of study treatment) Absolute neutrophil count ≥ 1.5 x 10^9/L Platelets ≥ 100 x 10^9/L Albumin ≥ 2.5 g/dL Total bilirubin ≤ 1.5 x upper limit of normal (ULN) Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 x ULN without liver metastases (≤ 5 x ULN if liver metastases are present) Estimated creatinine clearance ≥ 30 mL/min Prothrombin time/international normalized ratio (INR) and partial thromboplastin time ≤ 1.5 x ULN (except for subjects receiving anticoagulation therapy) Exclusion Criteria: Subject has received other investigational treatment within 28 days prior to randomization. Subject has received radiotherapy for metastatic pancreatic adenocarcinoma ≤ 14 days prior to randomization and has not recovered from any related toxicity. Subject has received systemic immunosuppressive therapy, including systemic corticosteroids within 14 days prior to randomization. Subject using a physiologic replacement dose of hydrocortisone or its equivalent (defined as up to 30 mg per day of hydrocortisone or up to 10 mg per day of prednisone), receiving a single dose of systemic corticosteroids or receiving systemic corticosteroids as premedication for radiologic imaging contrast use are allowed. Subject has prior severe allergic reaction or intolerance to known ingredients of zolbetuximab or other monoclonal antibody, including humanized or chimeric antibodies. Subject has known immediate or delayed hypersensitivity, intolerance or contraindication to any component of study treatment. Subject has a known history of a positive test for human immunodeficiency virus infection or known active hepatitis B (positive HBs antigen [Ag]) or hepatitis C infection. NOTE: Screening for these infections should be conducted per local requirements. For subjects who are negative for HBs Ag, but hepatitis B core antibody positive, a hepatitis B virus DNA test will be performed and if positive, the subject will be excluded. Subjects with positive hepatitis C serology but negative hepatitis C virus RNA test results are eligible. Subjects treated for hepatitis C with undetectable viral load results are eligible. Subject has a history of interstitial pneumonia or pulmonary fibrosis. Subject has pleural effusion or ascites ≥ Grade 3. Subject has an active autoimmune disease that has required systemic treatment in the past 3 months prior to randomization. Subject has active infection requiring systemic therapy that has not completely resolved per investigator judgment within 7 days prior to randomization. Subject has significant cardiovascular disease, including: Congestive heart failure (defined as New York Heart Association Class III or IV), myocardial infarction, unstable angina, coronary angioplasty, coronary stenting, coronary artery bypass graft, cerebrovascular accident or hypertensive crisis within 6 months prior to randomization; History of clinically significant ventricular arrhythmias (i.e., sustained ventricular tachycardia, ventricular fibrillation or Torsades de Pointes); QTc interval > 450 msec for male subjects; QTc interval > 470 msec for female subjects; Cardiac arrhythmias requiring anti-arrhythmic medications (Subjects with rate controlled atrial fibrillation for > 1 month prior to randomization.) Subject has a history of central nervous system metastases and/or carcinomatous meningitis from pancreatic adenocarcinoma. Subject has known peripheral sensory neuropathy ≥ Grade 2 unless the absence of deep tendon reflexes is the sole neurological abnormality. Subject has had a major surgical procedure ≤ 28 days prior to randomization. Subject without complete recovery from a major surgical procedure ≤ 14 days prior to randomization. Psychiatric illness or social situations that would preclude study compliance. Subject has another malignancy for which treatment is required. Subject has any concurrent disease, infection or co-morbid condition that interferes with the ability of the subject to participate in the study, which places the subject at undue risk or complicates the interpretation of data.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Astellas Pharma Global Development
Phone
800-888-7704
Email
astellas.registration@astellas.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Astellas Pharma Global Development
Official's Role
Study Director
Facility Information:
Facility Name
Cancer Treatment Centers of Phoenix
City
Goodyear
State/Province
Arizona
ZIP/Postal Code
85338
Country
United States
Individual Site Status
Withdrawn
Facility Name
St. Joseph Heritage Medical Group
City
Fullerton
State/Province
California
ZIP/Postal Code
92835
Country
United States
Individual Site Status
Recruiting
Facility Name
Hoag Hospital
City
Newport Beach
State/Province
California
ZIP/Postal Code
92663
Country
United States
Individual Site Status
Recruiting
Facility Name
UCLA Hematology Oncology
City
Santa Monica
State/Province
California
ZIP/Postal Code
90404
Country
United States
Individual Site Status
Withdrawn
Facility Name
TOI Clinical research
City
Whittier
State/Province
California
ZIP/Postal Code
90603
Country
United States
Individual Site Status
Recruiting
Facility Name
Midstate Medical Center
City
Meriden
State/Province
Connecticut
ZIP/Postal Code
06451
Country
United States
Individual Site Status
Recruiting
Facility Name
Lynn Cancer Institute
City
Boca Raton
State/Province
Florida
ZIP/Postal Code
33486
Country
United States
Individual Site Status
Recruiting
Facility Name
Baptist Health
City
Miami
State/Province
Florida
ZIP/Postal Code
33176
Country
United States
Individual Site Status
Recruiting
Facility Name
Cancer Treatment Centers of Atlanta
City
Newnan
State/Province
Georgia
ZIP/Postal Code
30265
Country
United States
Individual Site Status
Completed
Facility Name
University of Illinois at Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Individual Site Status
Recruiting
Facility Name
The University of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Individual Site Status
Withdrawn
Facility Name
Cancer Treatment Centers of America, Chicago
City
Zion
State/Province
Illinois
ZIP/Postal Code
60099
Country
United States
Individual Site Status
Withdrawn
Facility Name
PMG Research of McFarland Clinic
City
Ames
State/Province
Iowa
ZIP/Postal Code
50010
Country
United States
Individual Site Status
Withdrawn
Facility Name
Holden Comprehensive Cancer Center
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Kansas Cancer Center
City
Westwood
State/Province
Kansas
ZIP/Postal Code
66205
Country
United States
Individual Site Status
Withdrawn
Facility Name
Norton Cancer Institute (NCI)
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Individual Site Status
Recruiting
Facility Name
Our Lady of the Lake
City
Baton Rouge
State/Province
Louisiana
ZIP/Postal Code
70809
Country
United States
Individual Site Status
Withdrawn
Facility Name
Ochsner Health System
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70121
Country
United States
Individual Site Status
Completed
Facility Name
David C Pratt Cancer Center
City
Creve Coeur
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Individual Site Status
Completed
Facility Name
St Vincent's Frontier Cancer Center
City
Billings
State/Province
Montana
ZIP/Postal Code
59102
Country
United States
Individual Site Status
Recruiting
Facility Name
Memorial Sloan Kettering Basking Ridge
City
Basking Ridge
State/Province
New Jersey
ZIP/Postal Code
07920
Country
United States
Individual Site Status
Recruiting
Facility Name
Memorial Sloan Kettering Monmouth
City
Middletown
State/Province
New Jersey
ZIP/Postal Code
07748
Country
United States
Individual Site Status
Recruiting
Facility Name
Memorial Sloan Kettering Bergen
City
Montvale
State/Province
New Jersey
ZIP/Postal Code
07645
Country
United States
Individual Site Status
Recruiting
Facility Name
Roswell Park Cancer Institute
City
Buffalo
State/Province
New York
ZIP/Postal Code
14203
Country
United States
Individual Site Status
Recruiting
Facility Name
Memorial Sloan Kettering Commack
City
Commack
State/Province
New York
ZIP/Postal Code
11725
Country
United States
Individual Site Status
Recruiting
Facility Name
Memorial Sloan Kettering Westchester
City
Harrison
State/Province
New York
ZIP/Postal Code
10604
Country
United States
Individual Site Status
Recruiting
Facility Name
Northwell Health Cancer Institute
City
Lake Success
State/Province
New York
ZIP/Postal Code
11042
Country
United States
Individual Site Status
Completed
Facility Name
Memorial Sloan-Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10022
Country
United States
Individual Site Status
Recruiting
Facility Name
Memorial Sloan Kettering Nassau
City
Uniondale
State/Province
New York
ZIP/Postal Code
11553
Country
United States
Individual Site Status
Recruiting
Facility Name
Novant Health Presbyterian Medical Center
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28204
Country
United States
Individual Site Status
Recruiting
Facility Name
Novant Health
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Individual Site Status
Recruiting
Facility Name
Mercy Clinic Oklahoma Communities, Inc
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73120
Country
United States
Individual Site Status
Withdrawn
Facility Name
Cancer Treatment Centers of America at Eastern Regional Medical Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19124
Country
United States
Individual Site Status
Withdrawn
Facility Name
Oncology Consultants PA
City
Houston
State/Province
Texas
ZIP/Postal Code
77024
Country
United States
Individual Site Status
Withdrawn
Facility Name
Houston Methodist Hospital
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Name
Scott and White Memorial Hospital
City
Temple
State/Province
Texas
ZIP/Postal Code
76508
Country
United States
Individual Site Status
Withdrawn
Facility Name
Utah Cancer Specialists
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84106
Country
United States
Individual Site Status
Recruiting
Facility Name
Inova Dwight and Martha Schar
City
Fairfax
State/Province
Virginia
ZIP/Postal Code
22031
Country
United States
Individual Site Status
Recruiting
Facility Name
MultiCare Regional Cancer Center - Gig Harbor
City
Gig Harbor
State/Province
Washington
ZIP/Postal Code
98335
Country
United States
Individual Site Status
Recruiting
Facility Name
Vista Oncology
City
Olympia
State/Province
Washington
ZIP/Postal Code
98502
Country
United States
Individual Site Status
Recruiting
Facility Name
Virginia Mason
City
Seattle
State/Province
Washington
ZIP/Postal Code
98101
Country
United States
Individual Site Status
Recruiting
Facility Name
Site AU61008
City
Gosford
State/Province
New South Wales
ZIP/Postal Code
NSW 2250
Country
Australia
Individual Site Status
Recruiting
Facility Name
Site AU61007
City
Wollongong
State/Province
New South Wales
ZIP/Postal Code
HVGM+3C
Country
Australia
Individual Site Status
Recruiting
Facility Name
Site AU61002
City
North Adelaide
State/Province
South Australia
ZIP/Postal Code
5006
Country
Australia
Individual Site Status
Withdrawn
Facility Name
Site AU61005
City
Fitzroy
State/Province
Victoria
ZIP/Postal Code
5XRF+WX
Country
Australia
Individual Site Status
Recruiting
Facility Name
Site AU61006
City
Warrnambool
State/Province
Victoria
ZIP/Postal Code
VIC 3280
Country
Australia
Individual Site Status
Recruiting
Facility Name
Site BR55003
City
Itajai
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Site BR55002
City
Porto Alegre
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Site BR55008
City
Rio Grande Do Sul
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Site BR55004
City
Santa Catarina
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Site BR55001
City
Sao Paulo
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Site BR55006
City
Sao Paulo
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Site CN86001
City
Beijing
Country
China
Individual Site Status
Recruiting
Facility Name
Site CN86008
City
Beijing
Country
China
Individual Site Status
Recruiting
Facility Name
Site CN86014
City
Beijing
Country
China
Individual Site Status
Recruiting
Facility Name
Site CN86026
City
Changchun
Country
China
Individual Site Status
Recruiting
Facility Name
Site CN86009
City
Chongqing
Country
China
Individual Site Status
Recruiting
Facility Name
Site CN86004
City
Guangdong
Country
China
Individual Site Status
Recruiting
Facility Name
Site CN86020
City
Guangdong
Country
China
Individual Site Status
Recruiting
Facility Name
Site CN86016
City
Guangzhou
Country
China
Individual Site Status
Recruiting
Facility Name
Site CN86012
City
Harbin
Country
China
Individual Site Status
Recruiting
Facility Name
Site CN86002
City
Hubei
Country
China
Individual Site Status
Recruiting
Facility Name
Site CN86005
City
Jiangsu
Country
China
Individual Site Status
Recruiting
Facility Name
Site CN86011
City
Jiangsu
Country
China
Individual Site Status
Recruiting
Facility Name
Site CN86025
City
Jiangsu
Country
China
Individual Site Status
Recruiting
Facility Name
Site CN86024
City
Shan XI
Country
China
Individual Site Status
Recruiting
Facility Name
Site CN86023
City
Shandong
Country
China
Individual Site Status
Recruiting
Facility Name
Site CN86006
City
Shanghai
Country
China
Individual Site Status
Recruiting
Facility Name
Site CN86013
City
Shanghai
Country
China
Individual Site Status
Recruiting
Facility Name
Site CN86019
City
Shanghai
Country
China
Individual Site Status
Recruiting
Facility Name
Site CN86017
City
Shijiazhuang
Country
China
Individual Site Status
Recruiting
Facility Name
Site CN86007
City
Tianjin
Country
China
Individual Site Status
Recruiting
Facility Name
Site CN86022
City
Xinjiang
Country
China
Individual Site Status
Recruiting
Facility Name
Site CN86003
City
Zhejiang
Country
China
Individual Site Status
Recruiting
Facility Name
Site CN86018
City
Zhejiang
Country
China
Individual Site Status
Recruiting
Facility Name
Site CN86010
City
Zhengzhou
Country
China
Individual Site Status
Recruiting
Facility Name
Site FR33008
City
Besancon
State/Province
Besancon Cedex
ZIP/Postal Code
6XG7+42
Country
France
Individual Site Status
Recruiting
Facility Name
Site FR33010
City
Brest
State/Province
Brest Cedex
ZIP/Postal Code
9GV7+4G
Country
France
Individual Site Status
Recruiting
Facility Name
Site FR33004
City
Saint-Étienne
State/Province
Cedex 02
ZIP/Postal Code
42000
Country
France
Individual Site Status
Withdrawn
Facility Name
Site FR33015
City
Caen
State/Province
Cedex 5
ZIP/Postal Code
14076
Country
France
Individual Site Status
Recruiting
Facility Name
Site FR33006
City
Chambray
State/Province
Cedex 9
ZIP/Postal Code
37170
Country
France
Individual Site Status
Recruiting
Facility Name
Site FR33011
City
Dijon
State/Province
Dijon Cedex
ZIP/Postal Code
21079
Country
France
Individual Site Status
Recruiting
Facility Name
Site FR33012
City
Herblain
State/Province
Herblain Cedex
ZIP/Postal Code
44805
Country
France
Individual Site Status
Recruiting
Facility Name
Site FR33016
City
La Chaussee Saint Victor
State/Province
Loir-et-Cher
ZIP/Postal Code
41260
Country
France
Individual Site Status
Recruiting
Facility Name
Site FR33009
City
Nancy
State/Province
Nancy Cedex
ZIP/Postal Code
54000
Country
France
Individual Site Status
Recruiting
Facility Name
Site FR33017
City
Rouen
State/Province
Normandy
ZIP/Postal Code
76000
Country
France
Individual Site Status
Recruiting
Facility Name
Site FR33003
City
Aquitaine
State/Province
Pessac
ZIP/Postal Code
33604
Country
France
Individual Site Status
Recruiting
Facility Name
Site FR33013
City
Villejuif
State/Province
Villejuif Cedex
ZIP/Postal Code
94805
Country
France
Individual Site Status
Recruiting
Facility Name
Site FR33001
City
Bayonne Cedex
ZIP/Postal Code
64109
Country
France
Individual Site Status
Recruiting
Facility Name
Site FR33018
City
Bordeaux
Country
France
Individual Site Status
Recruiting
Facility Name
Site FR33002
City
Grenoble
Country
France
Individual Site Status
Recruiting
Facility Name
Site FR33020
City
Lyon Cedex
Country
France
Individual Site Status
Recruiting
Facility Name
Site FR33021
City
Nice Cedex 2
Country
France
Individual Site Status
Recruiting
Facility Name
Site FR33023
City
Pierre Benite
Country
France
Individual Site Status
Recruiting
Facility Name
Site FR33014
City
Plerin
ZIP/Postal Code
22190
Country
France
Individual Site Status
Recruiting
Facility Name
Site FR33005
City
Pringy Cedex
ZIP/Postal Code
74374
Country
France
Individual Site Status
Recruiting
Facility Name
Site FR33019
City
Roche-Sur-Yon
Country
France
Individual Site Status
Recruiting
Facility Name
Site FR33007
City
Strasbourg
ZIP/Postal Code
67000
Country
France
Individual Site Status
Recruiting
Facility Name
Site IR35301
City
Elm Park
State/Province
Dublin
ZIP/Postal Code
D04 T6F4
Country
Ireland
Individual Site Status
Recruiting
Facility Name
Site IE35303
City
Cork
ZIP/Postal Code
T12 DV56
Country
Ireland
Individual Site Status
Recruiting
Facility Name
Site IT39006
City
Rozzano
State/Province
Milan
ZIP/Postal Code
20089
Country
Italy
Individual Site Status
Recruiting
Facility Name
Site IT39004
City
Candiolo
State/Province
Torino
ZIP/Postal Code
10060
Country
Italy
Individual Site Status
Recruiting
Facility Name
Site IT39009
City
Ancona
Country
Italy
Individual Site Status
Recruiting
Facility Name
Site IT39015
City
Bologna
Country
Italy
Individual Site Status
Recruiting
Facility Name
Site IT39002
City
Cremona
ZIP/Postal Code
26100
Country
Italy
Individual Site Status
Recruiting
Facility Name
Site IT39012
City
Lazio
Country
Italy
Individual Site Status
Recruiting
Facility Name
Site IT39010
City
Lombardia
Country
Italy
Individual Site Status
Recruiting
Facility Name
Site IT39003
City
Milan
ZIP/Postal Code
20141
Country
Italy
Individual Site Status
Recruiting
Facility Name
Site IT39014
City
Toscana
Country
Italy
Individual Site Status
Recruiting
Facility Name
Site IT39008
City
Veneto
Country
Italy
Individual Site Status
Recruiting
Facility Name
Site JP81007
City
Nagoya
State/Province
Aichi
Country
Japan
Individual Site Status
Recruiting
Facility Name
Site JP81001
City
Kashiwa
State/Province
Chiba
Country
Japan
Individual Site Status
Recruiting
Facility Name
Site JP81005
City
Sapporo
State/Province
Hokkaido
Country
Japan
Individual Site Status
Recruiting
Facility Name
Site JP81006
City
Yokohama
State/Province
Kanagawa
Country
Japan
Individual Site Status
Recruiting
Facility Name
Site JP81003
City
Kashihara
State/Province
Nara
Country
Japan
Individual Site Status
Recruiting
Facility Name
Site JP81008
City
Suita
State/Province
Osaka
Country
Japan
Individual Site Status
Recruiting
Facility Name
Site JP81011
City
Bunkyo-ku
State/Province
Tokyo
Country
Japan
Individual Site Status
Recruiting
Facility Name
Site JP81012
City
Chuo-ku
State/Province
Tokyo
Country
Japan
Individual Site Status
Recruiting
Facility Name
Site JP81014
City
Koto-ku
State/Province
Tokyo
Country
Japan
Individual Site Status
Recruiting
Facility Name
Site JP81013
City
Mitaka
State/Province
Tokyo
Country
Japan
Individual Site Status
Recruiting
Facility Name
Site JP81002
City
Shinjuku-ku
State/Province
Tokyo
Country
Japan
Individual Site Status
Recruiting
Facility Name
Site JP81015
City
Ube
State/Province
Yamaguchi
Country
Japan
Individual Site Status
Recruiting
Facility Name
Site JP81004
City
Fukuoka
Country
Japan
Individual Site Status
Recruiting
Facility Name
Site JP81010
City
Osaka
Country
Japan
Individual Site Status
Completed
Facility Name
Site JP81009
City
Wakayama
Country
Japan
Individual Site Status
Recruiting
Facility Name
Site KR82005
City
Seongnam-Si
State/Province
Gyeonggi-do
ZIP/Postal Code
013620
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Site KR82008
City
Suwon-si
State/Province
Gyeonggi-do
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Site KR82010
City
Daegu
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Site KR82009
City
Gyeonggi-do
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Site KR82011
City
Jeollanam-do
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Site KR82001
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Site KR82003
City
Seoul
ZIP/Postal Code
120-752
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Site KR82004
City
Seoul
ZIP/Postal Code
138-736
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Site KR82007
City
Seoul
ZIP/Postal Code
152-703
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Site KR82002
City
Seoul
ZIP/Postal Code
F3QP+76
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Site KR82006
City
Seoul
ZIP/Postal Code
G234+36
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Site MX52004
City
Distrito Federal
Country
Mexico
Individual Site Status
Recruiting
Facility Name
Site MX52003
City
San Luis Potosi
Country
Mexico
Individual Site Status
Recruiting
Facility Name
Site MX52005
City
Veracruz
Country
Mexico
Individual Site Status
Recruiting
Facility Name
Site ES34004
City
Llobregat
State/Province
Barcelona
ZIP/Postal Code
08908
Country
Spain
Individual Site Status
Recruiting
Facility Name
Site ES34001
City
Sabadell
State/Province
Barcelona
ZIP/Postal Code
8208
Country
Spain
Individual Site Status
Recruiting
Facility Name
Site ES34011
City
A Coruna
State/Province
Galicia
ZIP/Postal Code
15009
Country
Spain
Individual Site Status
Withdrawn
Facility Name
Site ES34003
City
Pamplona
State/Province
Navarra
ZIP/Postal Code
31008
Country
Spain
Individual Site Status
Recruiting
Facility Name
Site ES34010
City
Barcelona
ZIP/Postal Code
08028
Country
Spain
Individual Site Status
Recruiting
Facility Name
Site ES34013
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Individual Site Status
Recruiting
Facility Name
Site ES34007
City
Barcelona
ZIP/Postal Code
08916
Country
Spain
Individual Site Status
Recruiting
Facility Name
Site ES34018
City
Barcelona
Country
Spain
Individual Site Status
Recruiting
Facility Name
Site ES34021
City
Barcelona
Country
Spain
Individual Site Status
Recruiting
Facility Name
Site ES34014
City
Caceres
ZIP/Postal Code
10003
Country
Spain
Individual Site Status
Recruiting
Facility Name
Site ES34025
City
Castello de la plana
Country
Spain
Individual Site Status
Recruiting
Facility Name
Site ES34022
City
Cordoba
Country
Spain
Individual Site Status
Recruiting
Facility Name
Site ES34002
City
Girona
ZIP/Postal Code
17007
Country
Spain
Individual Site Status
Recruiting
Facility Name
Site ES34005
City
Lleida
ZIP/Postal Code
25198
Country
Spain
Individual Site Status
Recruiting
Facility Name
Site ES34015
City
Madrid
ZIP/Postal Code
28027
Country
Spain
Individual Site Status
Active, not recruiting
Facility Name
Site ES34016
City
Madrid
ZIP/Postal Code
28027
Country
Spain
Individual Site Status
Recruiting
Facility Name
Site ES34006
City
Madrid
ZIP/Postal Code
28033
Country
Spain
Individual Site Status
Recruiting
Facility Name
Site ES34009
City
Madrid
ZIP/Postal Code
28034
Country
Spain
Individual Site Status
Recruiting
Facility Name
Site ES34012
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Individual Site Status
Withdrawn
Facility Name
Site ES34008
City
Madrid
ZIP/Postal Code
28050
Country
Spain
Individual Site Status
Recruiting
Facility Name
Site ES34020
City
Madrid
Country
Spain
Individual Site Status
Recruiting
Facility Name
Site ES34026
City
Malaga
Country
Spain
Individual Site Status
Recruiting
Facility Name
Site ES34024
City
Santander
Country
Spain
Individual Site Status
Recruiting
Facility Name
Site ES34017
City
Santiago de Compostela
Country
Spain
Individual Site Status
Recruiting
Facility Name
Site TW88604
City
Tainan
State/Province
East District
ZIP/Postal Code
70457
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
Site TW88606
City
Taoyuan
State/Province
Guishan District
ZIP/Postal Code
83301
Country
Taiwan
Individual Site Status
Withdrawn
Facility Name
Site TW88607
City
Tainan City
State/Province
Liuying District
ZIP/Postal Code
73657
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
Site TW88608
City
New Taipei City
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
Site TW88602
City
Taichung City
ZIP/Postal Code
5M5J+36
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
Site TW88603
City
Tainan City
ZIP/Postal Code
26CC+4Q
Country
Taiwan
Individual Site Status
Withdrawn
Facility Name
Site TW88605
City
Taipei City
ZIP/Postal Code
2GR9+7H
Country
Taiwan
Individual Site Status
Withdrawn
Facility Name
Site TW88601
City
Taipei City
ZIP/Postal Code
4G9C+W3
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
Site TW88609
City
Taipei City
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
Site TR90004
City
Ankara
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Site TR90006
City
Ankara
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Site TR90003
City
Diyarbakir
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Site TR90002
City
Istanbul
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Site TR90005
City
Istanbul
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Site TR90001
City
Konya
Country
Turkey
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Access to anonymized individual participant level data collected during the study, in addition to study-related supporting documentation, is planned for studies conducted with approved product indications and formulations, as well as compounds terminated during development. Studies conducted with product indications or formulations that remain active in development are assessed after study completion to determine if Individual Participant Data can be shared. Conditions and exceptions are described under the Sponsor Specific Details for Astellas on www.clinicalstudydatarequest.com.
IPD Sharing Time Frame
Access to participant level data is offered to researchers after publication of the primary manuscript (if applicable) and is available as long as Astellas has legal authority to provide the data.
IPD Sharing Access Criteria
Researchers must submit a proposal to conduct a scientifically relevant analysis of the study data. The research proposal is reviewed by an Independent Research Panel. If the proposal is approved, access to the study data is provided in a secure data sharing environment after receipt of a signed Data Sharing Agreement.
IPD Sharing URL
https://www.clinicalstudydatarequest.com/

Learn more about this trial

A Study to Assess the Efficacy and Safety of IMAB362 in Combination With Nab-Paclitaxel and Gemcitabine (Nab-P + GEM) as First Line Treatment in Subjects With Claudin 18.2 (CLDN18.2) Positive, Metastatic Pancreatic Adenocarcinoma

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