Using PET Imaging to Detect Cancer Cells in Patients with Certain Cancers

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

This study is testing a new imaging method to see if it can help find cancer cells in patients with pancreatic, colorectal, and bladder cancers who have high levels of a specific marker called CA19-9.

Quick facts

• Phase: PHASE1
• Study type: Interventional
• Enrollment: 22 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Memorial Sloan Kettering Cancer Center (other)
• Drugs / interventions: radiation
• Locations: 1 site (New York, New York)
• Trial ID: NCT05737615 on ClinicalTrials.gov

What this trial studies

This study aims to determine the highest safe dose and optimal dosing schedule of hu5B1-TCO and 64Cu-Tz-SarAr for identifying cancer cells that are positive for CA19-9. It will also assess the radiation exposure from 64Cu-Tz-SarAr and analyze how the body processes this agent. The study focuses on patients with pancreatic, colorectal, and bladder cancers, particularly those with elevated CA19-9 levels. Participants will undergo PET scans and pharmacokinetic evaluations as part of the intervention.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with confirmed pancreatic ductal adenocarcinoma or other specified cancers and elevated CA19-9 levels.

Not a fit: Patients without elevated CA19-9 levels or those with cancers not specified in the study may not benefit from this intervention.

Why it matters

Potential benefit: If successful, this study could enhance the detection of cancer cells in patients, leading to improved treatment outcomes.

How similar studies have performed: Other studies have shown promise in using PET imaging for cancer detection, suggesting potential success for this approach.

Eligibility criteria

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.

Where this trial is running

New York, New York

• Memorial Sloan Kettering Cancer Center — New York, New York, United States (RECRUITING)

Study contacts

• Principal investigator: Neeta Pandit-Taskar, MD — Memorial Sloan Kettering Cancer Center
• Study coordinator: Neeta Pandit-Taskar, MD

Conditions: Pancreatic Cancer, Pancreatic Ductal Adenocarcinoma, Metastatic Pancreatic Ductal Adenocarcinoma, Primary Pancreatic Ductal Adenocarcinoma, Metastatic Pancreatic Cancer, hu5B1-TCO, 64Cu-Tz-SarAr, 20-409