Recruiting
Phase 1

PET Imaging

Sponsor:

Memorial Sloan Kettering Cancer Center

Code:

NCT05737615

Conditions

Pancreatic Cancer

Pancreatic Ductal Adenocarcinoma

Metastatic Pancreatic Ductal Adenocarcinoma

Primary Pancreatic Ductal Adenocarcinoma

Metastatic Pancreatic Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

PET Scan

hu5B1-TCO

64Cu-Tz-SarAr

Pharmacokinetics

Study Details

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 ID

NCT05737615

Start date

Feb 10, 2023

Status verified date

Jul, 2025

Completion date

Feb 10, 2026

Anticipated

Primary completion date

Feb 10, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

22 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

experimental: Participants with Pancreatic Cancer

Participants have histologically confirmed primary or metastatic pancreatic ductal adenocarcinoma

Interventions

PET Scan

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

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.

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.

Pharmacokinetics

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

Primary outcome measure

  • SUV mean measurement [ Time Frame: 28 months ]

Central Contacts and Locations

Central contacts

Locations

Memorial Sloan Kettering Cancer Center

Recruiting

New York, New York, United States, 10065

Contacts

Somali Gavane, MD

212-639-2403

More Information

Sponsor

Memorial Sloan Kettering Cancer Center

Last update posted

Jul 10, 2025

Last verified

Jul, 2025

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Memorial Sloan Kettering Cancer Center on 2025-07-10.