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

Phase 1

Recruiting

• Conditions: Pancreatic Ductal Adenocarcinoma; Metastatic Pancreatic Ductal Adenocarcinoma; Primary Pancreatic Ductal Adenocarcinoma; Pancreatic Cancer; Metastatic Pancreatic Cancer
• Interventions: Diagnostic Test: PET Scan; Drug: hu5B1-TCO; Drug: 64Cu-Tz-SarAr; Diagnostic Test: Pharmacokinetics

• Registration Number: NCT05737615
• Lead Sponsor: Memorial Sloan Kettering Cancer Center

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-02-10
• Study First Submitted: 2023-02-10
• Study First Submitted QC: 2023-02-10
• Study First Posted: 2023-02-21
• Status Verified: 2025-03
• Last Update Submitted: 2025-05-13
• Last Update Posted: 2025-05-16
• Primary Completion: 2026-02-10
• Study Completion: 2026-02-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 22

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Participants with Pancreatic Cancer	PET Scan	Participants have histologically confirmed primary or metastatic pancreatic ductal adenocarcinoma
Participants with Pancreatic Cancer	Pharmacokinetics	Participants have histologically confirmed primary or metastatic pancreatic ductal adenocarcinoma
Participants with Pancreatic Cancer	64Cu-Tz-SarAr	Participants have histologically confirmed primary or metastatic pancreatic ductal adenocarcinoma
Participants with Pancreatic Cancer	hu5B1-TCO	Participants have histologically confirmed primary or metastatic pancreatic ductal adenocarcinoma

Primary Outcome Measures

Name	Time	Method
SUV mean measurement	28 months	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

Trial Locations

Locations (1)

Memorial Sloan Kettering Cancer Center; 🇺🇸 New York, New York, United States