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

Launched by MEMORIAL SLOAN KETTERING CANCER CENTER · Feb 10, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new imaging technique that uses a special substance called hu5B1-TCO and a radioactive material known as 64Cu-Tz-SarAr. The goal is to find the safest dose of these substances and the best way to use them for detecting certain types of cancer cells, particularly those linked to a marker called CA19-9. This marker is often found in higher levels in patients with pancreatic, colorectal, or bladder cancers. The trial will also look at how much radiation participants are exposed to and how their bodies process this new imaging substance.

To be eligible for the trial, participants need to be at least 18 years old and have a confirmed diagnosis of specific cancers, such as pancreatic ductal adenocarcinoma or other solid tumors with high CA19-9 levels. They should have at least one measurable tumor and be in overall decent health. Participants will undergo imaging tests and may need to provide samples to help researchers understand how the treatment works. It’s important to note that individuals with uncontrolled infections, recent major surgeries, or certain health conditions may not qualify for the study.

Gender

ALL

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.