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First-in-Human Study of XMT-1536 in Cancers Likely to Express NaPi2b

Primary Purpose

Platinum Resistant Ovarian Cancer, Non Small Cell Lung Cancer Metastatic

Status
Recruiting
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
upifitamab rilsodotin
Sponsored by
Mersana Therapeutics
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Platinum Resistant Ovarian Cancer

Eligibility Criteria

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

General Inclusion Criteria (for Dose Escalation, Expansion, and UPLIFT):

  • ECOG performance status 0 or 1
  • Measurable disease as per RECIST, version 1.1
  • Resolution of all acute toxic effects of prior therapy or surgical procedures to ≤Grade 1 (except alopecia, stable immune-related toxicity such as hypothyroidism on hormone replacement, adrenal insufficiency on ≤10 mg daily prednisone [or equivalent], chronic Grade 2 peripheral sensory neuropathy after prior taxane therapy).
  • Cardiac left ventricular ejection fraction (LVEF) ≥50% or ≥ the institution's lower limit of normal by either Echo or MUGA scan

  • Adequate organ function as defined by the following criteria:

    1. Absolute neutrophil count (ANC) ≥1500 cells/mm3
    2. Platelet count ≥100,000/mm3
    3. Hemoglobin ≥9 g/dL
    4. In patients not on anticoagulation therapy: INR, activated partial thromboplastin time (aPTT), and prothrombin time (PT) all within 1.2 times the institution's upper limit of normal (ULN). Patients on anticoagulation therapy are allowed if their relevant laboratory values are within the therapeutic window.
    5. Estimated glomerular filtration rate (GFR) ≥45 mL/min
    6. Total bilirubin ≤ULN
    7. g. Patients with asymptomatic elevations in unconjugated bilirubin due to Gilbert syndrome or stable chronic hemolytic anemia (e.g., hereditary spherocytosis, sickle cell disease, thalassemia intermedia) may be eligible after discussion with the Sponsor Medical Monitor.
  • Aspartate aminotransferase (AST or SGOT) and alanine aminotransferase (ALT or SGPT) ≤1.5 times the institutional ULN.
  • Albumin ≥3.0 g/dL
  • Able to provide informed consent.

General Exclusion Criteria (for Dose Escalation, Expansion, and UPLIFT) :

  • Major surgery within 28 days of starting study treatment, systemic anti-cancer therapy within the lesser of 28 days or 5 half-lives of the prior therapy before starting study treatment, or recent radiation therapy with unresolved toxicity or within a time window of potential toxicity.
  • Patients with untreated CNS metastases (including new and progressive brain metastases), history of leptomeningeal metastasis or carcinomatous meningitis.
  • Current known active infection with HIV, hepatitis B virus, or hepatitis C virus.
  • Prior history of liver disease such as liver cirrhosis, hepatic fibrosis
  • Current severe, uncontrolled systemic disease (e.g., clinically significant cardiovascular, pulmonary, or metabolic disease) or intercurrent illness that could interfere with per-protocol evaluations.
  • Current use of either constant or intermittent supplementary oxygen therapy.
  • History of suspected pneumonitis or interstitial lung disease.
  • Pregnant or nursing women.
  • History of other malignancy within the last 2 years, except for appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, or other malignancy with a similar expected curative outcome.
  • Active corneal disease, or history of corneal disease within 12 months prior to enrollment
  • Use of strong CYP450 3A inhibitors or inducers that cannot be discontinued while receiving study treatment
  • Oxygen saturation on room air <93%

Ovarian Cancer Inclusion Criteria for UPLIFT:

  • Histological diagnosis of high grade serous ovarian cancer, which includes fallopian tube, or primary peritoneal cancer, that is metastatic or recurrent.

  • Platinum-resistant disease

    1. Patients who have only had 1 line of platinum-based therapy must have received at least 4 cycles of platinum, must have had a response [complete response/remission (CR) or partial response/remission (PR)], and then progressed between 3 months and ≤ 6 months after the date of the last dose of platinum
    2. Patients who have received 2 to 4 lines of prior therapy must have received at least 4 cycles of platinum and then progressed within 6 months after the date of the last dose of platinum

  • One to 4 prior lines of systemic therapy for ovarian cancer

    a. Prior treatment with bevacizumab is required for patients with 1 to 2 prior lines of therapy

  • Patients must be willing to provide an archival tumor tissue block or slides or if not available, undergo procedure to obtain a new tumor biopsy using a low-risk, medically routine procedure

Ovarian Cancer Exclusion Criteria for UPLIFT:

  • Low-grade, clear cell, endometrioid, mucinous, carcinosarcoma, germ-cell, mixed histology, or stromal tumors
  • Prior treatment with mirvetuximab soravtansine or another ADC containing an antitubulin payload
  • Primary platinum-resistant disease, defined by a lack of response or by progression within 3 months after completing front-line, platinum-containing therapy.
  • Participation in DES or EXP segments of this study

Ovarian Cancer Inclusion Criteria for QTc sub-study:

Note: patients must meet all UPLIFT cohort inclusion criteria in order to participate in the QTc sub-study

• Study patient has agreed to remain in the clinic for the additional QTc related study activities on the Day 1 of Cycle 1 and Cycle 3.

Ovarian Cancer Exclusion Criteria for QTc sub-study:

  • Use of strong CYP450 3A inducers.
  • Uncontrolled cardiac arrhythmias, for example, atrial fibrillation with a ventricular response at rest > 100 beats per minute. left bundle branch block (LBBB)
  • Known abnormality of any cardiac valve (either stenosis or regurgitation) that is greater than moderate in severity.
  • Subjects not in sinus rhythm at screening with HR >45- <100
  • Any ECG abnormality that can interfere with the measurement of the QT interval

Sites / Locations

  • UAB Women & Infants Center
  • University of Alabama at Birmingham
  • Arizona Oncology Associates, PC - HAL
  • Arizona Oncology Associates
  • Highlands Oncology Group
  • Cedars Sinai Medical Center
  • Kaiser Permanente Medical Center - Oakland
  • University of California - IrvineRecruiting
  • Kaiser Permanente Medical Center - Roseville
  • Kaiser Permanente Medical Center - Sacramento
  • Kaiser Permanente Medical Center - South San Francisco
  • Kaiser Permanente Medical Center - San Francisco
  • Kaiser Permanente Medical Center - San Jose
  • Kaiser Permanente Medical Center - San Leandro
  • Sansum Clinic
  • Kaiser Permanente Medical Center - Santa Clara
  • Kaiser Permanente Medical Center - Vallejo
  • Kaiser Permanente Medical Center - Walnut Creek
  • University of Colorado
  • Rocky Mountain Cancer Centers, LLP
  • Holy Cross Hospital
  • University of Florida
  • Mayo Clinic - Jacksonville
  • University of Miami - Miller School of Medicine
  • Miami Cancer Institute
  • H. Lee Moffitt Cancer Center
  • Emory University
  • Georgia Cancer Center at Augusta University
  • University of Chicago
  • Maryland Oncology and Hematology
  • Massachusetts General Hospital
  • Dana Farber Cancer Insititute
  • Dana Farber Cancer Institute
  • Lahey Clinic
  • Baystate Medical Center
  • Karmanos Cancer InstituteRecruiting
  • Henry Ford Hospital
  • QUEST Research Institute
  • START - Midwest
  • START-Midwest
  • University of Minnesota
  • Mayo Clinic - Rochester
  • Washington University
  • Billings Clinic
  • Nebraska Methodist Hospital
  • MD Anderson Cancer Center at Cooper - Camden
  • Southwest Women's Oncology- Optimum Clinical Research GroupRecruiting
  • Women's Cancer Care Associates, LLC
  • NYU Langone Health
  • Mount Sinai Hospital
  • Levine Cancer Institute
  • Novant Health Cancer Institute
  • University of Cincinnati Medical Center
  • The Ohio State University Wexner Medical CenterRecruiting
  • Kattering Medical Center
  • Stephenson Cancer Centre-University of Oklahoma
  • Oklahoma Cancer Specialists and Research Institute
  • Willamette Valley Cancer Institute
  • Perelman Center for Advanced MedicineRecruiting
  • Fox Chase Cancer Center
  • Allegheny Health Network
  • UPMC Cancer Pavillion
  • Women & Infants Hospital of Rhode Island
  • Medical University of South Carolina
  • Institute of Transnational Oncology-Greenville Hospital System University Medical Center
  • Avera Cancer Institute
  • University of Tennessee
  • Sarah Cannon Research Institute
  • Texas Oncology, Austin
  • Texas Oncology-Austin
  • Texas Oncology- Bedford
  • Mary Crowley Cancer Research CenterRecruiting
  • Texas Oncology - Baylor Charles A. Sammons Cancer Center
  • Texas Oncology Baylor Charles A. Sammons Cancer Center
  • Texas Oncology, Fort Worth
  • Texas Oncology-Fort Worth Cancer CenterRecruiting
  • Texas Oncology P.A. - Harlingen
  • Baylor College of Medicine
  • Texas Oncology, HoustonRecruiting
  • US Oncology Research/Investigational Product Center
  • South Texas Accelerated Research Therapeutics (START)
  • NEXT Oncology
  • University of Utah Huntsman Cancer Institute
  • University of Virginia- Emily Couric Clinical Cancer Center
  • Virginia Cancer SpecialistRecruiting
  • VCU Massey Cancer CenterRecruiting
  • Virginia Commonwealth University Massey Cancer Center
  • BlueRidge Cancer Care Physicians
  • Oncology & Hematology Associates of Southwest Virginia, Inc. - Salem
  • University of Washington
  • Medical College Of Wisconsin
  • Austin Health - Olivia Newton John Cancer Center
  • Blacktown Road
  • Chris OBrien Lifehouse
  • Chris O'Brien Lifehouse
  • Royal Brisbane and Women's Hospital
  • Peter MacCallum Cancer Center
  • Icon Cancer Centre South Brisbane
  • University Hospital Graz
  • University Hospital Innsbruck - Tyrolean Hospital
  • Our Dear Lady Hospital, Aalst Campus
  • Saint Luc University Hospital
  • Campus Kennedylaan, President Kennedylaan 4
  • Herestraat 49
  • Avenue de l'Hopital 1
  • Multiprofile Hospital for Active Treatment" Park Hospital EOOD
  • Complex Oncology Center - Burgas
  • Multiprofile Hospital for Active Treatment "Serdika", Sofia
  • MHAT for Women's Health "Nadezhda"
  • Multiprofile Hospital for Active Treatment "Sofiamed", Sofia
  • Multiprofile Hospital for Active Treatment - Uni Hospital, Panagyurishte
  • British Columbia Cancer Agency
  • McGill University Health Centre - The Montreal General Hospital
  • Tom Baker Cancer Center
  • Sherbrooke University Hospital Centre
  • Princess Margaret Cancer Centre
  • University Hospital Brno
  • General University Hospital in Prague
  • University Hospital Bulovka
  • Rigshospitalet - University Hospital Copenhagen
  • Odense University Hospital
  • Tampere University Hospital
  • Francois Baclesse Center
  • Leon Berard Center
  • Montpellier Cancer Institute
  • Confluent Private Hospital
  • South Lyon Hospital Center, Department of Clinical Hematology
  • Strasbourg Europe Institut of Cancerology
  • Institute Claudius Regaud
  • Gustave Roussy
  • National Institute of Oncology
  • University of Debrecen Clinical Center
  • Petz Aladar University Teaching Hospital
  • Polyclinic S. Orsola-Malpighi
  • Hospital Cannizzaro - Catania
  • Hospital San Raffaele, IRCCS
  • National Cancer Institute - IRCCS "Fondazione G. Pascale"
  • University Hospital Campus Bio-Medico
  • National Cancer Institute Regina Elena, IRCCS
  • University Polyclinic Foundation "Agostino Gemelli" - IRCCS
  • Institute of Cancer Research and Treatment of Candiolo
  • National Cancer Institute
  • Vilnius University Hospital Santaros Klinikos
  • Auckland District Health Board, Auckland City Hospital
  • Oslo University Hospital, Rikshospitalet (The National Hospital)
  • Maria Sklodowska-Curie Bialystok Oncology Center
  • University Teaching Hospital in Bialystok
  • University Clinical Center, Clinic of Gynecology
  • Provincial Hospitals in Gdynia Sp. z o.o. (LLC)
  • Heliodor Swiecicki Clinical Hospital at the Karol Marcinkowski Medical University in Poznan
  • University Hospital Germans Trias i PujolRecruiting
  • University Hospital Vall d'Hebron
  • Hospital Clinic of Barcelona
  • University Clinical Hospital Virgen de la Arrixaca
  • Jaen Hospital ComplexRecruiting
  • Clinica Univ di NavarraRecruiting
  • Navarra University Clinic
  • University Hospital Clinical San CarlosRecruiting
  • University Hospital Foundation Jimenez DiazRecruiting
  • Hospital Universitario La Paz
  • La Paz University Hospital
  • Clara Campal Comprehensive Cancer CenterRecruiting
  • University Hospital Virgen del Rocio (HUVR)Recruiting
  • University Clinical Hospital of ValenciaRecruiting
  • Lund University, Department of Oncology
  • Addenbrooke's Hospital
  • Beatson West of Scotland Cancer Center
  • University College London Hospitals NHS Foundation Trust
  • Guy's Hospital
  • Royal Marsden Hospital - London, Gynae Trials Unit
  • The Christie NHS Foundation Trust
  • Mount Vernon Hospital, Cancer Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

Dose Escalation

Dose Expansion - Ovarian Cancer

Dose Expansion - NSCLC adenocarcinoma

Pivotal Cohort (UPLIFT)

QTc Sub-Study

Arm Description

XMT-1536 (upifitamab rilsodotin) treatment is administered in groups of patients who will receive doses that increase over time. This cohort is closed to enrollment.

Once the maximum tolerated dose or recommended Phase 2 dose is achieved in dose escalation, new groups of patients will receive XMT-1536 (upifitamab rilsodotin) at this fixed-dose. This cohort is closed to enrollment.

Once the maximum tolerated dose or recommended Phase 2 dose is achieved in dose escalation, new groups of patients will receive XMT-1536 (upifitamab rilsodotin) at this fixed-dose. This cohort is closed to enrollment.

Patients with platinum-resistant ovarian cancer will receive XMT-1536 (upifitamab rilsodotin) to further confirm the efficacy

For sites participating in the sub-study, patients with platinum -resistant ovarian cancer will have the option to enroll in this sub-study to evaluate potential changes in the QTc interval following administration of XMT-1536.

Outcomes

Primary Outcome Measures

DES: Maximum tolerated dose or recommended Phase 2 dose
Evaluate adverse events and concomitant medication use after XMT-1536 (upifitamab rilsodotin) doses
DES and EXP: Safety and Tolerability
Evaluate incidence and severity of adverse events
EXP: Anti-neoplastic effects of XMT-1536 (upifitamab rilsodotin)
Monitor tumor size
UPLIFT: Investigator-assessed objective response rate (ORR) of XMT-1536 (upifitamab rilsodotin) in the ITT-Higher NaPi2b population
Confirmed ORR is defined as the proportion of patients who have achieved a confirmed complete response (CR) or partial response (PR) per RECIST v1.1 after the initiation of study treatment.
QTc Sub-study: Evaluation of the concentration response analysis of XMT-1536 versus the change in QTcF values
"The concentration-QTcf change from baseline deltaQTcF analysis and analysis of central tendency for deltaQTcF

Secondary Outcome Measures

DES and EXP: Time of maximum observed concentration of XMT-1536 (upifitamab rilsodotin)
Determine the pharmacokinetics of XMT-1536 (upifitamab rilsodotin)
DES and EXP: Maximum concentration of XMT-1536 (upifitamab rilsodotin)
Determine the pharmacokinetics of XMT-1536 (upifitamab rilsodotin)
DES and EXP: Area under the concentration curve of the last measurable concentration of XMT-1536 (upifitamab rilsodotin)
Determine the pharmacokinetics of XMT-1536 (upifitamab rilsodotin)
DES: Anti-neoplastic effects of XMT-1536 (upifitamab rilsodotin)
Monitor tumor size
DES and EXP: Anti-drug antibody and neutralizing antibody
Analyze blood for antibodies to XMT-1536 (upifitamab rilsodotin) and neutralizing antibodies
UPLIFT: Confirmed Investigator-assessed objective response rate of XMT-1536 (upifitamab rilsodotin) regardless of NaPi2b expression
Assess the confirmed investigator-assessed objective response rate of XMT-1536 (upifitamab rilsodotin) regardless of NaPi2b expression
UPLIFT: Confirmed objective response rate by independent radiology review (IRR) for patients with high NaPi2b and overall
Assess the confirmed objective response rate by IRR for patients with high NaPi2b (TPS >/=75) and overall
UPLIFT: Duration of objective response (DOR)
Assess the duration of objective response (DOR) in patients who achieve a response
UPLIFT: Incidence and severity of adverse events
Evaluate incidence and severity of adverse events
QTc Sub-Study: Evaluation of the effect of XMT-1536 on QTcF in patients with platinum-resistant HGSOC by timepoint analysis
Con.-QTc evaluation
QTc Sub-Study: Evaluation of the effect of XMT-1536 on the PR-interval (PR), QRS duration (QRS), Heart Rate (HR), and ECG morphology
Con.-QTc evaluation

Full Information

First Posted
October 17, 2017
Last Updated
January 23, 2023
Sponsor
Mersana Therapeutics
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1. Study Identification

Unique Protocol Identification Number
NCT03319628
Brief Title
First-in-Human Study of XMT-1536 in Cancers Likely to Express NaPi2b
Official Title
A Phase 1b/2, First-in-Human, Dose Escalation and Expansion Study of XMT-1536 In Patients With Solid Tumors Likely to Express NaPi2b
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 12, 2017 (Actual)
Primary Completion Date
April 30, 2023 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mersana Therapeutics

4. Oversight

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

5. Study Description

Brief Summary
First-in-human, Phase 1b/2 safety study of the antibody-drug conjugate (ADC) XMT-1536 (upifitamab rilsodotin) administered as an intravenous infusion once every four weeks. Patients with tumor types likely to express NaPi2b were enrolled in dose escalation. Patients with platinum-resistant ovarian cancer and non-small cell lung cancer (adenocarcinoma subtype) were enrolled in the expansion segment of this study. Patients with platinum-resistant, high-grade serous ovarian cancer are being enrolled in the UPLIFT segment of this study. In addition to safety assessments, the pharmacokinetics of the drug will be assessed along with ADC activity. A QTc sub-study has been added for the UPLIFT cohort for a sub-set of sites.
Detailed Description
This is a multi-center study of XMT-1536 (upifitamab rilsodotin) in patients with tumors likely to express NaPi2b, focusing on patients with platinum-resistant ovarian cancer and non-small cell lung cancer, adenocarcinoma subtype. XMT-1536 (upifitamab rilsodotin) will be administered as an intravenous infusion once every four weeks. The study consists of three segments: dose escalation (DES), dose expansion (EXP), and the pivotal cohort (UPLIFT). The DES segment studied small groups of patients who received increased doses. A Safety Review Committee was established to review the data from each dose level before moving to the next higher dose. The dose escalation cohort has ended and is no longer enrolling patients. Enrollment into the EXP segment consists of 2 parallel cohorts of patients to confirm the dose that has been identified in DES and estimate the objective response rate in each patient population. The EXP cohort is no longer enrolling patients. Enrollment into the pivotal cohort (UPLIFT) includes patients with platinum-resistant ovarian cancer. All adverse events will be graded according to the National Cancer Institute (NCI) Common Terminology Criteria version (CTCAE v5.0). Throughout the study, pharmacokinetics will be measured using proprietary assays developed by Mersana. Anti-cancer activity will be measured via RECIST.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Platinum Resistant Ovarian Cancer, Non Small Cell Lung Cancer Metastatic

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Model Description
Open-label, dose escalation to reach MTD. The MTD will be confirmed in parallel cohorts: patients with platinum-resistant ovarian cancer; patients with non-squamous NSCLC, adenocarcinoma subtype
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
444 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Dose Escalation
Arm Type
Experimental
Arm Description
XMT-1536 (upifitamab rilsodotin) treatment is administered in groups of patients who will receive doses that increase over time. This cohort is closed to enrollment.
Arm Title
Dose Expansion - Ovarian Cancer
Arm Type
Experimental
Arm Description
Once the maximum tolerated dose or recommended Phase 2 dose is achieved in dose escalation, new groups of patients will receive XMT-1536 (upifitamab rilsodotin) at this fixed-dose. This cohort is closed to enrollment.
Arm Title
Dose Expansion - NSCLC adenocarcinoma
Arm Type
Experimental
Arm Description
Once the maximum tolerated dose or recommended Phase 2 dose is achieved in dose escalation, new groups of patients will receive XMT-1536 (upifitamab rilsodotin) at this fixed-dose. This cohort is closed to enrollment.
Arm Title
Pivotal Cohort (UPLIFT)
Arm Type
Experimental
Arm Description
Patients with platinum-resistant ovarian cancer will receive XMT-1536 (upifitamab rilsodotin) to further confirm the efficacy
Arm Title
QTc Sub-Study
Arm Type
Experimental
Arm Description
For sites participating in the sub-study, patients with platinum -resistant ovarian cancer will have the option to enroll in this sub-study to evaluate potential changes in the QTc interval following administration of XMT-1536.
Intervention Type
Drug
Intervention Name(s)
upifitamab rilsodotin
Other Intervention Name(s)
XMT-1536, UpRi
Intervention Description
XMT-1536 will be administered once every 28 days until disease progression, unacceptable toxicity, or either the patient or study physician determines it is in the best interest of the patient to discontinue participation in the study. For sites participating in the sub-study, patients with platinum -resistant ovarian cancer will have the option to enroll in this sub-study to evaluate potential changes in the QTc interval following administration of XMT-1536
Primary Outcome Measure Information:
Title
DES: Maximum tolerated dose or recommended Phase 2 dose
Description
Evaluate adverse events and concomitant medication use after XMT-1536 (upifitamab rilsodotin) doses
Time Frame
Up to 36 weeks, from the date of first dose until unacceptable side effects or a dose-limiting toxicity is met
Title
DES and EXP: Safety and Tolerability
Description
Evaluate incidence and severity of adverse events
Time Frame
First dose up until 30 days after study termination
Title
EXP: Anti-neoplastic effects of XMT-1536 (upifitamab rilsodotin)
Description
Monitor tumor size
Time Frame
Every 6 weeks for up to 36 weeks
Title
UPLIFT: Investigator-assessed objective response rate (ORR) of XMT-1536 (upifitamab rilsodotin) in the ITT-Higher NaPi2b population
Description
Confirmed ORR is defined as the proportion of patients who have achieved a confirmed complete response (CR) or partial response (PR) per RECIST v1.1 after the initiation of study treatment.
Time Frame
Every 8 weeks until disease progression or up to 24 months
Title
QTc Sub-study: Evaluation of the concentration response analysis of XMT-1536 versus the change in QTcF values
Description
"The concentration-QTcf change from baseline deltaQTcF analysis and analysis of central tendency for deltaQTcF
Time Frame
60 minutes prior to first dose, up to 26 hours after Cycle 3 dose
Secondary Outcome Measure Information:
Title
DES and EXP: Time of maximum observed concentration of XMT-1536 (upifitamab rilsodotin)
Description
Determine the pharmacokinetics of XMT-1536 (upifitamab rilsodotin)
Time Frame
Daily for one week after first dose; weekly until 28 days after first dose; immediately before and after and 1 week after all subsequent doses
Title
DES and EXP: Maximum concentration of XMT-1536 (upifitamab rilsodotin)
Description
Determine the pharmacokinetics of XMT-1536 (upifitamab rilsodotin)
Time Frame
Daily for one week after first dose; weekly until 28 days after first dose; immediately before and after and 1 week after all subsequent doses
Title
DES and EXP: Area under the concentration curve of the last measurable concentration of XMT-1536 (upifitamab rilsodotin)
Description
Determine the pharmacokinetics of XMT-1536 (upifitamab rilsodotin)
Time Frame
Daily for one week after first dose; weekly until 28 days after first dose; immediately before and after and 1 week after all subsequent doses
Title
DES: Anti-neoplastic effects of XMT-1536 (upifitamab rilsodotin)
Description
Monitor tumor size
Time Frame
Every 6 weeks for up to 36 weeks
Title
DES and EXP: Anti-drug antibody and neutralizing antibody
Description
Analyze blood for antibodies to XMT-1536 (upifitamab rilsodotin) and neutralizing antibodies
Time Frame
Every 6 weeks for up to 36 weeks
Title
UPLIFT: Confirmed Investigator-assessed objective response rate of XMT-1536 (upifitamab rilsodotin) regardless of NaPi2b expression
Description
Assess the confirmed investigator-assessed objective response rate of XMT-1536 (upifitamab rilsodotin) regardless of NaPi2b expression
Time Frame
Every 8 weeks until disease progression or up to 24 months
Title
UPLIFT: Confirmed objective response rate by independent radiology review (IRR) for patients with high NaPi2b and overall
Description
Assess the confirmed objective response rate by IRR for patients with high NaPi2b (TPS >/=75) and overall
Time Frame
Every 8 weeks until disease progression or up to 24 months
Title
UPLIFT: Duration of objective response (DOR)
Description
Assess the duration of objective response (DOR) in patients who achieve a response
Time Frame
4 weeks after first response and every 8 weeks until disease progression or up to 24 months
Title
UPLIFT: Incidence and severity of adverse events
Description
Evaluate incidence and severity of adverse events
Time Frame
First dose up until 60 days after study termination
Title
QTc Sub-Study: Evaluation of the effect of XMT-1536 on QTcF in patients with platinum-resistant HGSOC by timepoint analysis
Description
Con.-QTc evaluation
Time Frame
60 minutes prior to first dose, up to 26 hours after Cycle 3 dose
Title
QTc Sub-Study: Evaluation of the effect of XMT-1536 on the PR-interval (PR), QRS duration (QRS), Heart Rate (HR), and ECG morphology
Description
Con.-QTc evaluation
Time Frame
60 minutes prior to first dose, up to 26 hours after Cycle 3 dose

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
General Inclusion Criteria (for Dose Escalation, Expansion, and UPLIFT): ECOG performance status 0 or 1 Measurable disease as per RECIST, version 1.1 Resolution of all acute toxic effects of prior therapy or surgical procedures to ≤Grade 1 (except alopecia, stable immune-related toxicity such as hypothyroidism on hormone replacement, adrenal insufficiency on ≤10 mg daily prednisone [or equivalent], chronic Grade 2 peripheral sensory neuropathy after prior taxane therapy). Cardiac left ventricular ejection fraction (LVEF) ≥50% or ≥ the institution's lower limit of normal by either Echo or MUGA scan Adequate organ function as defined by the following criteria: Absolute neutrophil count (ANC) ≥1500 cells/mm3 Platelet count ≥100,000/mm3 Hemoglobin ≥9 g/dL In patients not on anticoagulation therapy: INR, activated partial thromboplastin time (aPTT), and prothrombin time (PT) all within 1.2 times the institution's upper limit of normal (ULN). Patients on anticoagulation therapy are allowed if their relevant laboratory values are within the therapeutic window. Estimated glomerular filtration rate (GFR) ≥45 mL/min Total bilirubin ≤ULN g. Patients with asymptomatic elevations in unconjugated bilirubin due to Gilbert syndrome or stable chronic hemolytic anemia (e.g., hereditary spherocytosis, sickle cell disease, thalassemia intermedia) may be eligible after discussion with the Sponsor Medical Monitor. Aspartate aminotransferase (AST or SGOT) and alanine aminotransferase (ALT or SGPT) ≤1.5 times the institutional ULN. Albumin ≥3.0 g/dL Able to provide informed consent. General Exclusion Criteria (for Dose Escalation, Expansion, and UPLIFT) : Major surgery within 28 days of starting study treatment, systemic anti-cancer therapy within the lesser of 28 days or 5 half-lives of the prior therapy before starting study treatment, or recent radiation therapy with unresolved toxicity or within a time window of potential toxicity. Patients with untreated CNS metastases (including new and progressive brain metastases), history of leptomeningeal metastasis or carcinomatous meningitis. Current known active infection with HIV, hepatitis B virus, or hepatitis C virus. Prior history of liver disease such as liver cirrhosis, hepatic fibrosis Current severe, uncontrolled systemic disease (e.g., clinically significant cardiovascular, pulmonary, or metabolic disease) or intercurrent illness that could interfere with per-protocol evaluations. Current use of either constant or intermittent supplementary oxygen therapy. History of suspected pneumonitis or interstitial lung disease. Pregnant or nursing women. History of other malignancy within the last 2 years, except for appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, or other malignancy with a similar expected curative outcome. Active corneal disease, or history of corneal disease within 12 months prior to enrollment Use of strong CYP450 3A inhibitors or inducers that cannot be discontinued while receiving study treatment Oxygen saturation on room air <93% Ovarian Cancer Inclusion Criteria for UPLIFT: Histological diagnosis of high grade serous ovarian cancer, which includes fallopian tube, or primary peritoneal cancer, that is metastatic or recurrent. Platinum-resistant disease Patients who have only had 1 line of platinum-based therapy must have received at least 4 cycles of platinum, must have had a response [complete response/remission (CR) or partial response/remission (PR)], and then progressed between 3 months and ≤ 6 months after the date of the last dose of platinum Patients who have received 2 to 4 lines of prior therapy must have received at least 4 cycles of platinum and then progressed within 6 months after the date of the last dose of platinum One to 4 prior lines of systemic therapy for ovarian cancer a. Prior treatment with bevacizumab is required for patients with 1 to 2 prior lines of therapy Patients must be willing to provide an archival tumor tissue block or slides or if not available, undergo procedure to obtain a new tumor biopsy using a low-risk, medically routine procedure Ovarian Cancer Exclusion Criteria for UPLIFT: Low-grade, clear cell, endometrioid, mucinous, carcinosarcoma, germ-cell, mixed histology, or stromal tumors Prior treatment with mirvetuximab soravtansine or another ADC containing an antitubulin payload Primary platinum-resistant disease, defined by a lack of response or by progression within 3 months after completing front-line, platinum-containing therapy. Participation in DES or EXP segments of this study Ovarian Cancer Inclusion Criteria for QTc sub-study: Note: patients must meet all UPLIFT cohort inclusion criteria in order to participate in the QTc sub-study • Study patient has agreed to remain in the clinic for the additional QTc related study activities on the Day 1 of Cycle 1 and Cycle 3. Ovarian Cancer Exclusion Criteria for QTc sub-study: Use of strong CYP450 3A inducers. Uncontrolled cardiac arrhythmias, for example, atrial fibrillation with a ventricular response at rest > 100 beats per minute. left bundle branch block (LBBB) Known abnormality of any cardiac valve (either stenosis or regurgitation) that is greater than moderate in severity. Subjects not in sinus rhythm at screening with HR >45- <100 Any ECG abnormality that can interfere with the measurement of the QT interval
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jamie Barrett
Phone
617-715-8214
Email
medicalinformation@mersana.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Leslie DeMars, MD
Organizational Affiliation
Mersana Therapeutics
Official's Role
Study Director
Facility Information:
Facility Name
UAB Women & Infants Center
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Arizona Oncology Associates, PC - HAL
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85712
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Arizona Oncology Associates
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85712
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Highlands Oncology Group
City
Springdale
State/Province
Arkansas
ZIP/Postal Code
72762
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Cedars Sinai Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Kaiser Permanente Medical Center - Oakland
City
Oakland
State/Province
California
ZIP/Postal Code
94611
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
University of California - Irvine
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jill Tseng, MD
First Name & Middle Initial & Last Name & Degree
Jill Tseng, MD
Facility Name
Kaiser Permanente Medical Center - Roseville
City
Roseville
State/Province
California
ZIP/Postal Code
95678
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Kaiser Permanente Medical Center - Sacramento
City
Sacramento
State/Province
California
ZIP/Postal Code
95814
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Kaiser Permanente Medical Center - South San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94112
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Kaiser Permanente Medical Center - San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Kaiser Permanente Medical Center - San Jose
City
San Jose
State/Province
California
ZIP/Postal Code
95116
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Kaiser Permanente Medical Center - San Leandro
City
San Leandro
State/Province
California
ZIP/Postal Code
94115
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Sansum Clinic
City
Santa Barbara
State/Province
California
ZIP/Postal Code
93105
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Kaiser Permanente Medical Center - Santa Clara
City
Santa Clara
State/Province
California
ZIP/Postal Code
95051
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Kaiser Permanente Medical Center - Vallejo
City
Vallejo
State/Province
California
ZIP/Postal Code
94503
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Kaiser Permanente Medical Center - Walnut Creek
City
Walnut Creek
State/Province
California
ZIP/Postal Code
94595
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
University of Colorado
City
Boulder
State/Province
Colorado
ZIP/Postal Code
80309
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Rocky Mountain Cancer Centers, LLP
City
Lone Tree
State/Province
Colorado
ZIP/Postal Code
80124
Country
United States
Individual Site Status
Withdrawn
Facility Name
Holy Cross Hospital
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
20910
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
University of Florida
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32611
Country
United States
Individual Site Status
Withdrawn
Facility Name
Mayo Clinic - Jacksonville
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32224
Country
United States
Individual Site Status
Withdrawn
Facility Name
University of Miami - Miller School of Medicine
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Miami Cancer Institute
City
Miami
State/Province
Florida
ZIP/Postal Code
33176
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
H. Lee Moffitt Cancer Center
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Individual Site Status
Withdrawn
Facility Name
Emory University
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Georgia Cancer Center at Augusta University
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30912
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
University of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60607
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Maryland Oncology and Hematology
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20817
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Dana Farber Cancer Insititute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Dana Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Lahey Clinic
City
Burlington
State/Province
Massachusetts
ZIP/Postal Code
01805
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Baystate Medical Center
City
Springfield
State/Province
Massachusetts
ZIP/Postal Code
01199
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Karmanos Cancer Institute
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kelly Schneider
Phone
313-576-9749
First Name & Middle Initial & Last Name & Degree
Ira Winer, MD
Facility Name
Henry Ford Hospital
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
QUEST Research Institute
City
Farmington Hills
State/Province
Michigan
ZIP/Postal Code
48334
Country
United States
Individual Site Status
Withdrawn
Facility Name
START - Midwest
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49546
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
START-Midwest
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49546
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
University of Minnesota
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Individual Site Status
Withdrawn
Facility Name
Mayo Clinic - Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Washington University
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63130
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Billings Clinic
City
Billings
State/Province
Montana
ZIP/Postal Code
59101
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Nebraska Methodist Hospital
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68114
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
MD Anderson Cancer Center at Cooper - Camden
City
Camden
State/Province
New Jersey
ZIP/Postal Code
08103
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Southwest Women's Oncology- Optimum Clinical Research Group
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87109
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Karen Finkelstein, MD
First Name & Middle Initial & Last Name & Degree
Karen Finkelstein, MD
Facility Name
Women's Cancer Care Associates, LLC
City
Albany
State/Province
New York
ZIP/Postal Code
12208
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
NYU Langone Health
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Mount Sinai Hospital
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Levine Cancer Institute
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28204
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Novant Health Cancer Institute
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28204
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
University of Cincinnati Medical Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45267
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
The Ohio State University Wexner Medical Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
John Hays, MD
First Name & Middle Initial & Last Name & Degree
John Hays, MD
Facility Name
Kattering Medical Center
City
Kettering
State/Province
Ohio
ZIP/Postal Code
45429
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Stephenson Cancer Centre-University of Oklahoma
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Oklahoma Cancer Specialists and Research Institute
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74146
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Willamette Valley Cancer Institute
City
Eugene
State/Province
Oregon
ZIP/Postal Code
97401
Country
United States
Individual Site Status
Withdrawn
Facility Name
Perelman Center for Advanced Medicine
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lainie Martin
First Name & Middle Initial & Last Name & Degree
Lainie Martin, MD
Facility Name
Fox Chase Cancer Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19111
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Allegheny Health Network
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15222
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
UPMC Cancer Pavillion
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15232
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Women & Infants Hospital of Rhode Island
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02905
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Institute of Transnational Oncology-Greenville Hospital System University Medical Center
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29604
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Avera Cancer Institute
City
Sioux Falls
State/Province
South Dakota
ZIP/Postal Code
57105
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
University of Tennessee
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37996
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Sarah Cannon Research Institute
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Texas Oncology, Austin
City
Austin
State/Province
Texas
ZIP/Postal Code
78705
Country
United States
Individual Site Status
Withdrawn
Facility Name
Texas Oncology-Austin
City
Austin
State/Province
Texas
ZIP/Postal Code
78731
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Texas Oncology- Bedford
City
Bedford
State/Province
Texas
ZIP/Postal Code
76022
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Mary Crowley Cancer Research Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75201
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Minal Barve, MD
First Name & Middle Initial & Last Name & Degree
Riser
Phone
972-566-3066
First Name & Middle Initial & Last Name & Degree
Minal Barve, MD
Facility Name
Texas Oncology - Baylor Charles A. Sammons Cancer Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Texas Oncology Baylor Charles A. Sammons Cancer Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Texas Oncology, Fort Worth
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76104
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Texas Oncology-Fort Worth Cancer Center
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76104
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Noelle Cloven
First Name & Middle Initial & Last Name & Degree
Noelle Cloven, MD
Facility Name
Texas Oncology P.A. - Harlingen
City
Harlingen
State/Province
Texas
ZIP/Postal Code
78550
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Baylor College of Medicine
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Texas Oncology, Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Donald Richards, MD
First Name & Middle Initial & Last Name & Degree
Donald Richards, MD
Facility Name
US Oncology Research/Investigational Product Center
City
Irving
State/Province
Texas
ZIP/Postal Code
75063
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
South Texas Accelerated Research Therapeutics (START)
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
NEXT Oncology
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78240
Country
United States
Individual Site Status
Withdrawn
Facility Name
University of Utah Huntsman Cancer Institute
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84112
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
University of Virginia- Emily Couric Clinical Cancer Center
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22903
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Virginia Cancer Specialist
City
Fairfax
State/Province
Virginia
ZIP/Postal Code
22031
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alex Spira, MD
First Name & Middle Initial & Last Name & Degree
Alex Spira, MD
Facility Name
VCU Massey Cancer Center
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23291
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Leslie Randall
First Name & Middle Initial & Last Name & Degree
Leslie Randall, MD
Facility Name
Virginia Commonwealth University Massey Cancer Center
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
BlueRidge Cancer Care Physicians
City
Roanoke
State/Province
Virginia
ZIP/Postal Code
24014
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Oncology & Hematology Associates of Southwest Virginia, Inc. - Salem
City
Salem
State/Province
Virginia
ZIP/Postal Code
24153
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
University of Washington
City
Seattle
State/Province
Washington
ZIP/Postal Code
98195
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Medical College Of Wisconsin
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Austin Health - Olivia Newton John Cancer Center
City
Heidelberg
State/Province
Victoria
Country
Australia
Individual Site Status
Withdrawn
Facility Name
Blacktown Road
City
Blacktown
ZIP/Postal Code
2148
Country
Australia
Individual Site Status
Active, not recruiting
Facility Name
Chris OBrien Lifehouse
City
Camperdown
ZIP/Postal Code
2050
Country
Australia
Individual Site Status
Active, not recruiting
Facility Name
Chris O'Brien Lifehouse
City
Camperdown
Country
Australia
Individual Site Status
Active, not recruiting
Facility Name
Royal Brisbane and Women's Hospital
City
Herston
ZIP/Postal Code
4029
Country
Australia
Individual Site Status
Withdrawn
Facility Name
Peter MacCallum Cancer Center
City
Melbourne
ZIP/Postal Code
3000
Country
Australia
Individual Site Status
Active, not recruiting
Facility Name
Icon Cancer Centre South Brisbane
City
South Brisbane
ZIP/Postal Code
4201
Country
Australia
Individual Site Status
Active, not recruiting
Facility Name
University Hospital Graz
City
Graz
ZIP/Postal Code
8036
Country
Austria
Individual Site Status
Active, not recruiting
Facility Name
University Hospital Innsbruck - Tyrolean Hospital
City
Innsbruck
ZIP/Postal Code
6020
Country
Austria
Individual Site Status
Active, not recruiting
Facility Name
Our Dear Lady Hospital, Aalst Campus
City
Aalst
ZIP/Postal Code
9300
Country
Belgium
Individual Site Status
Active, not recruiting
Facility Name
Saint Luc University Hospital
City
Brussel
ZIP/Postal Code
1200
Country
Belgium
Individual Site Status
Active, not recruiting
Facility Name
Campus Kennedylaan, President Kennedylaan 4
City
Kortrijk
ZIP/Postal Code
8500
Country
Belgium
Individual Site Status
Active, not recruiting
Facility Name
Herestraat 49
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Individual Site Status
Active, not recruiting
Facility Name
Avenue de l'Hopital 1
City
Liège
ZIP/Postal Code
4000
Country
Belgium
Individual Site Status
Active, not recruiting
Facility Name
Multiprofile Hospital for Active Treatment" Park Hospital EOOD
City
Branipole
ZIP/Postal Code
4109
Country
Bulgaria
Individual Site Status
Active, not recruiting
Facility Name
Complex Oncology Center - Burgas
City
Burgas
ZIP/Postal Code
8000
Country
Bulgaria
Individual Site Status
Active, not recruiting
Facility Name
Multiprofile Hospital for Active Treatment "Serdika", Sofia
City
Sofia
ZIP/Postal Code
1303
Country
Bulgaria
Individual Site Status
Active, not recruiting
Facility Name
MHAT for Women's Health "Nadezhda"
City
Sofia
ZIP/Postal Code
1330
Country
Bulgaria
Individual Site Status
Active, not recruiting
Facility Name
Multiprofile Hospital for Active Treatment "Sofiamed", Sofia
City
Sofia
ZIP/Postal Code
1797
Country
Bulgaria
Individual Site Status
Active, not recruiting
Facility Name
Multiprofile Hospital for Active Treatment - Uni Hospital, Panagyurishte
City
Sofia
ZIP/Postal Code
4500
Country
Bulgaria
Individual Site Status
Active, not recruiting
Facility Name
British Columbia Cancer Agency
City
Vancouver
State/Province
British Columbia
Country
Canada
Individual Site Status
Active, not recruiting
Facility Name
McGill University Health Centre - The Montreal General Hospital
City
Montreal
State/Province
Quebec
Country
Canada
Individual Site Status
Active, not recruiting
Facility Name
Tom Baker Cancer Center
City
Calgary
ZIP/Postal Code
T2N 4N2
Country
Canada
Individual Site Status
Active, not recruiting
Facility Name
Sherbrooke University Hospital Centre
City
Québec
ZIP/Postal Code
J1G 2E8
Country
Canada
Individual Site Status
Active, not recruiting
Facility Name
Princess Margaret Cancer Centre
City
Toronto
ZIP/Postal Code
M5G 2M9
Country
Canada
Individual Site Status
Active, not recruiting
Facility Name
University Hospital Brno
City
Brno
ZIP/Postal Code
625 00
Country
Czechia
Individual Site Status
Active, not recruiting
Facility Name
General University Hospital in Prague
City
Prague
ZIP/Postal Code
110 00
Country
Czechia
Individual Site Status
Active, not recruiting
Facility Name
University Hospital Bulovka
City
Prague
ZIP/Postal Code
180 81
Country
Czechia
Individual Site Status
Active, not recruiting
Facility Name
Rigshospitalet - University Hospital Copenhagen
City
Copenhagen
ZIP/Postal Code
DK-2100
Country
Denmark
Individual Site Status
Active, not recruiting
Facility Name
Odense University Hospital
City
Odense
ZIP/Postal Code
DK-5230
Country
Denmark
Individual Site Status
Active, not recruiting
Facility Name
Tampere University Hospital
City
Tampere
ZIP/Postal Code
33520
Country
Finland
Individual Site Status
Active, not recruiting
Facility Name
Francois Baclesse Center
City
Caen
ZIP/Postal Code
14076
Country
France
Individual Site Status
Active, not recruiting
Facility Name
Leon Berard Center
City
Montpellier
ZIP/Postal Code
34298
Country
France
Individual Site Status
Active, not recruiting
Facility Name
Montpellier Cancer Institute
City
Montpellier
ZIP/Postal Code
34298
Country
France
Individual Site Status
Active, not recruiting
Facility Name
Confluent Private Hospital
City
Nantes
ZIP/Postal Code
44277
Country
France
Individual Site Status
Active, not recruiting
Facility Name
South Lyon Hospital Center, Department of Clinical Hematology
City
Pierre-Bénite
ZIP/Postal Code
69495
Country
France
Individual Site Status
Active, not recruiting
Facility Name
Strasbourg Europe Institut of Cancerology
City
Strasbourg
ZIP/Postal Code
23025
Country
France
Individual Site Status
Withdrawn
Facility Name
Institute Claudius Regaud
City
Toulouse
ZIP/Postal Code
31059
Country
France
Individual Site Status
Active, not recruiting
Facility Name
Gustave Roussy
City
Villejuif
ZIP/Postal Code
94805
Country
France
Individual Site Status
Active, not recruiting
Facility Name
National Institute of Oncology
City
Budapest
ZIP/Postal Code
1122
Country
Hungary
Individual Site Status
Active, not recruiting
Facility Name
University of Debrecen Clinical Center
City
Debrecen
ZIP/Postal Code
4032
Country
Hungary
Individual Site Status
Active, not recruiting
Facility Name
Petz Aladar University Teaching Hospital
City
Győr
ZIP/Postal Code
9024
Country
Hungary
Individual Site Status
Active, not recruiting
Facility Name
Polyclinic S. Orsola-Malpighi
City
Bologna
ZIP/Postal Code
40138
Country
Italy
Individual Site Status
Withdrawn
Facility Name
Hospital Cannizzaro - Catania
City
Catania
ZIP/Postal Code
95126
Country
Italy
Individual Site Status
Active, not recruiting
Facility Name
Hospital San Raffaele, IRCCS
City
Milan
ZIP/Postal Code
20132
Country
Italy
Individual Site Status
Active, not recruiting
Facility Name
National Cancer Institute - IRCCS "Fondazione G. Pascale"
City
Naples
ZIP/Postal Code
80131
Country
Italy
Individual Site Status
Active, not recruiting
Facility Name
University Hospital Campus Bio-Medico
City
Rome
ZIP/Postal Code
00128
Country
Italy
Individual Site Status
Active, not recruiting
Facility Name
National Cancer Institute Regina Elena, IRCCS
City
Rome
ZIP/Postal Code
00144
Country
Italy
Individual Site Status
Active, not recruiting
Facility Name
University Polyclinic Foundation "Agostino Gemelli" - IRCCS
City
Rome
ZIP/Postal Code
00168
Country
Italy
Individual Site Status
Active, not recruiting
Facility Name
Institute of Cancer Research and Treatment of Candiolo
City
Turin
ZIP/Postal Code
10060
Country
Italy
Individual Site Status
Withdrawn
Facility Name
National Cancer Institute
City
Vilnius
ZIP/Postal Code
08660
Country
Lithuania
Individual Site Status
Active, not recruiting
Facility Name
Vilnius University Hospital Santaros Klinikos
City
Vilnius
ZIP/Postal Code
08661
Country
Lithuania
Individual Site Status
Active, not recruiting
Facility Name
Auckland District Health Board, Auckland City Hospital
City
Auckland
ZIP/Postal Code
1023
Country
New Zealand
Individual Site Status
Active, not recruiting
Facility Name
Oslo University Hospital, Rikshospitalet (The National Hospital)
City
Oslo
ZIP/Postal Code
0372
Country
Norway
Individual Site Status
Active, not recruiting
Facility Name
Maria Sklodowska-Curie Bialystok Oncology Center
City
Białystok
ZIP/Postal Code
15-027
Country
Poland
Individual Site Status
Active, not recruiting
Facility Name
University Teaching Hospital in Bialystok
City
Białystok
ZIP/Postal Code
15-276
Country
Poland
Individual Site Status
Active, not recruiting
Facility Name
University Clinical Center, Clinic of Gynecology
City
Gdańsk
ZIP/Postal Code
80-214
Country
Poland
Individual Site Status
Active, not recruiting
Facility Name
Provincial Hospitals in Gdynia Sp. z o.o. (LLC)
City
Gdynia
ZIP/Postal Code
81-519
Country
Poland
Individual Site Status
Active, not recruiting
Facility Name
Heliodor Swiecicki Clinical Hospital at the Karol Marcinkowski Medical University in Poznan
City
Poznań
ZIP/Postal Code
60-569
Country
Poland
Individual Site Status
Active, not recruiting
Facility Name
University Hospital Germans Trias i Pujol
City
Badalona
ZIP/Postal Code
08916
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Margarita Romeo Marin, MD
First Name & Middle Initial & Last Name & Degree
Margarita Romeo Marin, MD
Facility Name
University Hospital Vall d'Hebron
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Individual Site Status
Active, not recruiting
Facility Name
Hospital Clinic of Barcelona
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Individual Site Status
Active, not recruiting
Facility Name
University Clinical Hospital Virgen de la Arrixaca
City
El Palmar
ZIP/Postal Code
30120
Country
Spain
Individual Site Status
Active, not recruiting
Facility Name
Jaen Hospital Complex
City
Jaen
ZIP/Postal Code
23007
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fernando Galvez, MD
First Name & Middle Initial & Last Name & Degree
Fernando Galvez, MD
Facility Name
Clinica Univ di Navarra
City
Madrid
ZIP/Postal Code
28027
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Martin Gonzalez, MD
First Name & Middle Initial & Last Name & Degree
Martin Gonzalez, MD
Facility Name
Navarra University Clinic
City
Madrid
ZIP/Postal Code
28027
Country
Spain
Individual Site Status
Active, not recruiting
Facility Name
University Hospital Clinical San Carlos
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Aranzazu Manzano Fernandez, MD
First Name & Middle Initial & Last Name & Degree
Aranzazu Manzano Fernandez, MD
Facility Name
University Hospital Foundation Jimenez Diaz
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Victor Moreno Garcia, MD
First Name & Middle Initial & Last Name & Degree
Victor Moreno Garcia, MD
Facility Name
Hospital Universitario La Paz
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Individual Site Status
Active, not recruiting
Facility Name
La Paz University Hospital
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Individual Site Status
Active, not recruiting
Facility Name
Clara Campal Comprehensive Cancer Center
City
Madrid
ZIP/Postal Code
28050
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Emiliano Calvo, MD
First Name & Middle Initial & Last Name & Degree
Emiliano Calvo, MD
Facility Name
University Hospital Virgen del Rocio (HUVR)
City
Sevilla
ZIP/Postal Code
41013
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Purificacion Estevez, MD
First Name & Middle Initial & Last Name & Degree
Purificacion Estevez, MD
Facility Name
University Clinical Hospital of Valencia
City
Valencia
ZIP/Postal Code
46010
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jose Alejandro Perez Fidalgo, MD
First Name & Middle Initial & Last Name & Degree
Jose Alejandro Perez Fidalgo, MD
Facility Name
Lund University, Department of Oncology
City
Lund
ZIP/Postal Code
22100
Country
Sweden
Individual Site Status
Active, not recruiting
Facility Name
Addenbrooke's Hospital
City
Cambridge
ZIP/Postal Code
CB2 0QQ
Country
United Kingdom
Individual Site Status
Active, not recruiting
Facility Name
Beatson West of Scotland Cancer Center
City
Glasgow
ZIP/Postal Code
G12 0YN
Country
United Kingdom
Individual Site Status
Active, not recruiting
Facility Name
University College London Hospitals NHS Foundation Trust
City
London
ZIP/Postal Code
NW1 2PG
Country
United Kingdom
Individual Site Status
Active, not recruiting
Facility Name
Guy's Hospital
City
London
ZIP/Postal Code
SE1 9RT
Country
United Kingdom
Individual Site Status
Active, not recruiting
Facility Name
Royal Marsden Hospital - London, Gynae Trials Unit
City
London
ZIP/Postal Code
SM2 5PT
Country
United Kingdom
Individual Site Status
Active, not recruiting
Facility Name
The Christie NHS Foundation Trust
City
Manchester
ZIP/Postal Code
M20 4BX
Country
United Kingdom
Individual Site Status
Active, not recruiting
Facility Name
Mount Vernon Hospital, Cancer Center
City
Northwood
ZIP/Postal Code
HA6 2RN
Country
United Kingdom
Individual Site Status
Active, not recruiting

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

First-in-Human Study of XMT-1536 in Cancers Likely to Express NaPi2b

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