PET Imaging Using 64Cu-Tz-SarAr and hu5B1-TCO in People With Pancreatic, Colorectal, Bladder Cancer or Cancers With Elevated CA19.9

NCT ID: NCT05737615

Last Updated: 2025-09-04

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE1
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-02-10
• Study Completion Date: 2026-02-10

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.

Conditions

Pancreatic Cancer; Pancreatic Ductal Adenocarcinoma; Metastatic Pancreatic Ductal Adenocarcinoma; Primary Pancreatic Ductal Adenocarcinoma; Metastatic Pancreatic Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Participants with Pancreatic Cancer

Participants have histologically confirmed primary or metastatic pancreatic ductal adenocarcinoma

Group Type: EXPERIMENTAL

PET Scan

Intervention Type: DIAGNOSTIC_TEST

Participants will be imaged up to 4 time points post-injection to allow for biodistribution and dosimetry determination

hu5B1-TCO

Intervention Type: DRUG

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.

64Cu-Tz-SarAr

Intervention Type: DRUG

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.

Pharmacokinetics

Intervention Type: DIAGNOSTIC_TEST

All participants receiving 64Cu-Tz-SarAr will have serial blood samples drawn.

Interventions

PET Scan

Participants will be imaged up to 4 time points post-injection to allow for biodistribution and dosimetry determination

Intervention Type: DIAGNOSTIC_TEST

hu5B1-TCO

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

64Cu-Tz-SarAr

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

Pharmacokinetics

All participants receiving 64Cu-Tz-SarAr will have serial blood samples drawn.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

Patients will be eligible for enrollment if they fulfill the following criteria:

1. Signed informed consent

2. 18 years of age or older

3. Histologically confirmed primary or metastatic pancreatic ductal adenocarcinoma/bladder carcinoma / gastrointestinal tumor reviewed at MSK - includes patients with biopsy-proven or high suspicion on imaging for pancreatic ductal adenocarcinoma (PDAC) or histologically confirmed, locally-advanced, or metastatic pancreatic ductal adenocarcinoma (PDAC) of

Patient with solid tumors increased serum CA19-9 serum level greater than ULN or CA19-9 positive biopsy

4. At least one lesion by CT or MRI ≥ 2 cm unless determined otherwise for presurgery subjects 5. ECOG performance status of 0 to 2 6. 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) 10. 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:

1. Active, uncontrolled bacterial, viral, or fungal infection(s) requiring systemic therapy

2. Major surgery other than diagnostic surgery within 4 weeks of Study Day 1

3. History of anaphylactic reaction to human, or humanized, antibody

4. Other on-going cancer therapy with investigational agents

5. Known history of HIV

6. 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.

7. Psychiatric illness/social situations that would interfere with compliance with study requirements.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Memorial Sloan Kettering Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Somali Gavane, MD

Role: PRINCIPAL_INVESTIGATOR

Memorial Sloan Kettering Cancer Center

Related Links

http://www.mskcc.org

Memorial Sloan Kettering Cancer Center

Other Identifiers

20-409

Identifier Type: -

Identifier Source: org_study_id