NCT05737615

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.

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Feb 2023

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 10, 2023

Completed
Same day until next milestone

Study Start

First participant enrolled

February 10, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

February 21, 2023

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 10, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 10, 2026

Completed
Last Updated

September 4, 2025

Status Verified

August 1, 2025

Enrollment Period

3 years

First QC Date

February 10, 2023

Last Update Submit

August 27, 2025

Conditions

Pancreatic CancerPancreatic Ductal AdenocarcinomaMetastatic Pancreatic Ductal AdenocarcinomaPrimary Pancreatic Ductal AdenocarcinomaMetastatic Pancreatic Cancer

Keywords

Pancreatic CancerPancreatic Ductal AdenocarcinomaMetastatic Pancreatic Ductal AdenocarcinomaPrimary Pancreatic Ductal AdenocarcinomaMetastatic Pancreatic Cancerhu5B1-TCO64Cu-Tz-SarAr20-409Memorial Sloan Kettering Cancer Center

Outcome Measures

Primary Outcomes (1)

  • 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

    28 months

Study Arms (1)

Participants with Pancreatic Cancer

EXPERIMENTAL

Participants have histologically confirmed primary or metastatic pancreatic ductal adenocarcinoma

Diagnostic Test: PET ScanDrug: hu5B1-TCODrug: 64Cu-Tz-SarArDiagnostic Test: Pharmacokinetics

Interventions

PET ScanDIAGNOSTIC_TEST

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

Participants with Pancreatic Cancer
hu5B1-TCODRUG

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.

Participants with Pancreatic Cancer
64Cu-Tz-SarArDRUG

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.

Participants with Pancreatic Cancer
PharmacokineticsDIAGNOSTIC_TEST

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

Participants with Pancreatic Cancer

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients will be eligible for enrollment if they fulfill the following criteria:
  • Signed informed consent
  • years of age or older
  • 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
  • \. 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Links

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Positron-Emission TomographyPharmacokinetics

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsEndocrine Gland NeoplasmsDigestive System DiseasesPancreatic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Tomography, Emission-ComputedImage Interpretation, Computer-AssistedDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisImage EnhancementPhotographyRadionuclide ImagingTomographyDiagnostic Techniques, RadioisotopeMetabolismPharmacological and Toxicological PhenomenaPhysiological Phenomena

Study Officials

  • Somali Gavane, MD

    Memorial Sloan Kettering Cancer Center

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 10, 2023

First Posted

February 21, 2023

Study Start

February 10, 2023

Primary Completion

February 10, 2026

Study Completion

February 10, 2026

Last Updated

September 4, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will share

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.