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

Pancreatic Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05737615
• Other study ID #: 20-409
• Status: Recruiting
• Phase: Phase 1
• Start date: February 10, 2023
• Est. completion date: February 10, 2025

Study information

• Verified date: March 2024
• Source: Memorial Sloan Kettering Cancer Center
• Contact: Neeta Pandit-Taskar, MD
• Phone: 2126393046
• Email: pandit-n[@]MSKCC.ORG
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 22
• Est. completion date: February 10, 2025
• Est. primary completion date: February 10, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Adenocarcinoma
• Metastatic Pancreatic Cancer
• Metastatic Pancreatic Ductal Adenocarcinoma
• Pancreatic Cancer
• Pancreatic Ductal Adenocarcinoma
• Pancreatic Neoplasms

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Memorial Sloan Kettering Cancer Center	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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

External Links

•   Memorial Sloan Kettering Cancer Center