search
Back to results

PET Imaging Using 64Cu-Tz-SarAr and hu5B1-TCO in People With Pancreatic Cancer

Primary Purpose

Pancreatic Cancer, Pancreatic Ductal Adenocarcinoma, Metastatic Pancreatic Ductal Adenocarcinoma

Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
PET Scan
hu5B1-TCO
64Cu-Tz-SarAr
Pharmacokinetics
Sponsored by
Memorial Sloan Kettering Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Pancreatic Cancer focused on measuring Pancreatic Cancer, Pancreatic Ductal Adenocarcinoma, Metastatic Pancreatic Ductal Adenocarcinoma, Primary Pancreatic Ductal Adenocarcinoma, Metastatic Pancreatic Cancer, hu5B1-TCO, 64Cu-Tz-SarAr, 20-409, Memorial Sloan Kettering Cancer Center

Eligibility Criteria

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

Inclusion Criteria: Patients will be eligible for enrollment if they fulfill the following criteria: Signed informed consent 18 years of age or older Histologically confirmed primary or metastatic pancreatic ductal adenocarcinoma reviewed at MSK - includes patients with biopsy-proven or high suspicion on imaging for pancreatic ductal adenocarcinoma (PDAC) (Stage T2 and T3) or histologically confirmed, locally-advanced, or metastatic pancreatic ductal adenocarcinoma (PDAC). Patients who are surgical candidates for tumor resection or for biopsy or patients with metastatic disease, who are to undergo biopsy prior to standard of care treatment. Patients who have received neoadjuvant chemotherapy or radiation therapy who are scheduled to undergo surgery are eligible At least one lesion by CT or MRI ≥ 2 cm unless determined otherwise for presurgery subjects Patient with increased serum CA19-9 serum level greater than ULN or CA19-9 positive biopsy ECOG performance status of 0 to 2 Adequate laboratory parameters including: i. Absolute neutrophil count (ANC) ≥1.5 x 109 /L ii. Hemoglobin ≥ 9.0 g/dL iii. Platelet count >75,000/ mm3 iv. AST/SGOT, ALT/SGPT ≤2.5 x ULN, unless liver metastases are clearly present, then ≤5.0 x ULN v. Total bilirubin ≤ 1.5x the upper limit of normal unless considered due to Gilbert's syndrome in which case, ≤3x the upper limit of normal vi. Creatinine clearance (CLcr) (> 60 mL/min) estimated by the Cockcroft-Gault (C-G) equation or estimated glomerular filtration rate (eGFR) Willingness to participate in collection of pharmacokinetic samples Exclusion Criteria: Patients will be excluded from the study if they fulfill any of the following criteria: Active, uncontrolled bacterial, viral, or fungal infection(s) requiring systemic therapy Major surgery other than diagnostic surgery within 4 weeks of Study Day 1 History of anaphylactic reaction to human, or humanized, antibody Other on-going cancer therapy with investigational agents Known history of HIV Pregnant or currently breast-feeding a. Subjects and their partners with reproductive potential must agree to use an effective form of contraception during the study and for 1 week following the study treatment. Psychiatric illness/social situations that would interfere with compliance with study requirements.

Sites / Locations

  • Memorial Sloan Kettering Cancer CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Participants with Pancreatic Cancer

Arm Description

Participants have histologically confirmed primary or metastatic pancreatic ductal adenocarcinoma

Outcomes

Primary Outcome Measures

SUV mean measurement
The serial quantitative data obtained over the various organs of interest (heart, liver, spleen, kidney, lung and any other organ that exhibits uptake) will be collected

Secondary Outcome Measures

Full Information

First Posted
February 10, 2023
Last Updated
August 21, 2023
Sponsor
Memorial Sloan Kettering Cancer Center
search

1. Study Identification

Unique Protocol Identification Number
NCT05737615
Brief Title
PET Imaging Using 64Cu-Tz-SarAr and hu5B1-TCO in People With Pancreatic Cancer
Official Title
A Phase I Study of Pretargeted PET Imaging Using 64Cu-Tz-SarAr and a Trans-Cyclooctene-Modified Humanized 5B1 Immunoconjugate (hu5B1-TCO) in Patients With CA19-9-Positive Pancreatic Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 10, 2023 (Actual)
Primary Completion Date
February 10, 2025 (Anticipated)
Study Completion Date
February 10, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Memorial Sloan Kettering Cancer Center

4. Oversight

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

5. Study Description

Brief Summary
The purpose of this study is to find the highest safe dose of hu5B1-TCO and the best dosing schedule of hu5B1-TCO and 64Cu-Tz-SarAr for finding cancer cells that are CA19-9 positive. This study will also help to find out how much radiation the body is exposed to when 64Cu-Tz-SarAr is used, and provide information on the way the body absorbs, distributes, and gets rid of 64Cu-Tz-SarAr.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Cancer, Pancreatic Ductal Adenocarcinoma, Metastatic Pancreatic Ductal Adenocarcinoma, Primary Pancreatic Ductal Adenocarcinoma, Metastatic Pancreatic Cancer
Keywords
Pancreatic Cancer, Pancreatic Ductal Adenocarcinoma, Metastatic Pancreatic Ductal Adenocarcinoma, Primary Pancreatic Ductal Adenocarcinoma, Metastatic Pancreatic Cancer, hu5B1-TCO, 64Cu-Tz-SarAr, 20-409, Memorial Sloan Kettering Cancer Center

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
22 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Participants with Pancreatic Cancer
Arm Type
Experimental
Arm Description
Participants have histologically confirmed primary or metastatic pancreatic ductal adenocarcinoma
Intervention Type
Diagnostic Test
Intervention Name(s)
PET Scan
Intervention Description
Participants will be imaged up to 4 time points post-injection to allow for biodistribution and dosimetry determination
Intervention Type
Drug
Intervention Name(s)
hu5B1-TCO
Intervention Description
On study day 0, a single slow infusion of hu5B1-TCO will be administered intravenously. Subsequently, either 3 days (n = 3) or 5 days (n = 3) later, a single slow infusion of 64Cu-Tz-SarAr will be administered intravenously.
Intervention Type
Drug
Intervention Name(s)
64Cu-Tz-SarAr
Intervention Description
On study day 0, a single slow infusion of hu5B1-TCO will be administered intravenously. Subsequently, either 3 days (n = 3) or 5 days (n = 3) later, a single slow infusion of 64Cu-Tz-SarAr will be administered intravenously.
Intervention Type
Diagnostic Test
Intervention Name(s)
Pharmacokinetics
Intervention Description
All participants receiving 64Cu-Tz-SarAr will have serial blood samples drawn.
Primary Outcome Measure Information:
Title
SUV mean measurement
Description
The serial quantitative data obtained over the various organs of interest (heart, liver, spleen, kidney, lung and any other organ that exhibits uptake) will be collected
Time Frame
28 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients will be eligible for enrollment if they fulfill the following criteria: Signed informed consent 18 years of age or older Histologically confirmed primary or metastatic pancreatic ductal adenocarcinoma reviewed at MSK - includes patients with biopsy-proven or high suspicion on imaging for pancreatic ductal adenocarcinoma (PDAC) (Stage T2 and T3) or histologically confirmed, locally-advanced, or metastatic pancreatic ductal adenocarcinoma (PDAC). Patients who are surgical candidates for tumor resection or for biopsy or patients with metastatic disease, who are to undergo biopsy prior to standard of care treatment. Patients who have received neoadjuvant chemotherapy or radiation therapy who are scheduled to undergo surgery are eligible At least one lesion by CT or MRI ≥ 2 cm unless determined otherwise for presurgery subjects Patient with increased serum CA19-9 serum level greater than ULN or CA19-9 positive biopsy ECOG performance status of 0 to 2 Adequate laboratory parameters including: i. Absolute neutrophil count (ANC) ≥1.5 x 109 /L ii. Hemoglobin ≥ 9.0 g/dL iii. Platelet count >75,000/ mm3 iv. AST/SGOT, ALT/SGPT ≤2.5 x ULN, unless liver metastases are clearly present, then ≤5.0 x ULN v. Total bilirubin ≤ 1.5x the upper limit of normal unless considered due to Gilbert's syndrome in which case, ≤3x the upper limit of normal vi. Creatinine clearance (CLcr) (> 60 mL/min) estimated by the Cockcroft-Gault (C-G) equation or estimated glomerular filtration rate (eGFR) Willingness to participate in collection of pharmacokinetic samples Exclusion Criteria: Patients will be excluded from the study if they fulfill any of the following criteria: Active, uncontrolled bacterial, viral, or fungal infection(s) requiring systemic therapy Major surgery other than diagnostic surgery within 4 weeks of Study Day 1 History of anaphylactic reaction to human, or humanized, antibody Other on-going cancer therapy with investigational agents Known history of HIV Pregnant or currently breast-feeding a. Subjects and their partners with reproductive potential must agree to use an effective form of contraception during the study and for 1 week following the study treatment. Psychiatric illness/social situations that would interfere with compliance with study requirements.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Neeta Pandit-Taskar, MD
Phone
2126393046
Email
pandit-n@MSKCC.ORG
First Name & Middle Initial & Last Name or Official Title & Degree
Eileen O'Reilly, MD
Phone
6468884182
Email
oreillye@MSKCC.ORG
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Neeta Pandit-Taskar, MD
Organizational Affiliation
Memorial Sloan Kettering Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Memorial Sloan Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Neeta Pandit-Taskar, MD
Phone
212-639-3046

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.
Links:
URL
http://www.mskcc.org
Description
Memorial Sloan Kettering Cancer Center

Learn more about this trial

PET Imaging Using 64Cu-Tz-SarAr and hu5B1-TCO in People With Pancreatic Cancer

We'll reach out to this number within 24 hrs