- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05737615
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
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Phase 1
Contacts and Locations
Study Contact
- Name: Neeta Pandit-Taskar, MD
- Phone Number: 2126393046
- Email: pandit-n@MSKCC.ORG
Study Contact Backup
- Name: Eileen O'Reilly, MD
- Phone Number: 6468884182
- Email: oreillye@MSKCC.ORG
Study Locations
-
-
New York
-
New York, New York, United States, 10065
- Recruiting
- Memorial Sloan Kettering Cancer Center
-
Contact:
- Neeta Pandit-Taskar, MD
- Phone Number: 212-639-3046
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Study Population
Description
Inclusion Criteria:
Patients will be eligible for enrollment if they fulfill the following criteria:
- Signed informed consent
- 18 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
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:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Participants with Pancreatic Cancer
Participants have histologically confirmed primary or metastatic pancreatic ductal adenocarcinoma
|
Participants will be imaged up to 4 time points post-injection to allow for biodistribution and dosimetry determination
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.
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.
All participants receiving 64Cu-Tz-SarAr will have serial blood samples drawn.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
SUV mean measurement
Time Frame: 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
|
28 months
|
Collaborators and Investigators
Investigators
- Principal Investigator: Neeta Pandit-Taskar, MD, Memorial Sloan Kettering Cancer Center
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 20-409
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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