Trials / Withdrawn
WithdrawnNCT05737615
PET Imaging Using 64Cu-Tz-SarAr and hu5B1-TCO in People With Pancreatic, Colorectal, Bladder Cancer or Cancers With Elevated CA19.9
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 Pancreatic, Bladder Cancer, Gastrointestinal Malignancies or Solid Tumors With Elevated CA19-9
- Status
- Withdrawn
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 0 (actual)
- Sponsor
- Memorial Sloan Kettering Cancer Center · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| DIAGNOSTIC_TEST | PET Scan | Participants will be imaged up to 4 time points post-injection to allow for biodistribution and dosimetry determination |
| DRUG | 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. |
| 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. |
| DIAGNOSTIC_TEST | Pharmacokinetics | All participants receiving 64Cu-Tz-SarAr will have serial blood samples drawn. |
Timeline
- Start date
- 2023-02-10
- Primary completion
- 2026-02-10
- Completion
- 2026-02-10
- First posted
- 2023-02-21
- Last updated
- 2025-09-04
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05737615. Inclusion in this directory is not an endorsement.