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Trial Title:
PET Imaging Using 64Cu-Tz-SarAr and hu5B1-TCO in People With Pancreatic, Colorectal, Bladder Cancer or Cancers With Elevated CA19.9
NCT ID:
NCT05737615
Condition:
Pancreatic Cancer
Pancreatic Ductal Adenocarcinoma
Metastatic Pancreatic Ductal Adenocarcinoma
Primary Pancreatic Ductal Adenocarcinoma
Metastatic Pancreatic Cancer
Conditions: Official terms:
Adenocarcinoma
Pancreatic Neoplasms
Conditions: Keywords:
Pancreatic Cancer
Pancreatic Ductal Adenocarcinoma
Metastatic Pancreatic Ductal Adenocarcinoma
Primary Pancreatic Ductal Adenocarcinoma
Metastatic Pancreatic Cancer
hu5B1-TCO
64Cu-Tz-SarAr
20-409
Memorial Sloan Kettering Cancer Center
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Diagnostic
Masking:
None (Open Label)
Intervention:
Intervention type:
Diagnostic Test
Intervention name:
PET Scan
Description:
Participants will be imaged up to 4 time points post-injection to allow for
biodistribution and dosimetry determination
Arm group label:
Participants with Pancreatic Cancer
Intervention type:
Drug
Intervention name:
hu5B1-TCO
Description:
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.
Arm group label:
Participants with Pancreatic Cancer
Intervention type:
Drug
Intervention name:
64Cu-Tz-SarAr
Description:
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.
Arm group label:
Participants with Pancreatic Cancer
Intervention type:
Diagnostic Test
Intervention name:
Pharmacokinetics
Description:
All participants receiving 64Cu-Tz-SarAr will have serial blood samples drawn.
Arm group label:
Participants with Pancreatic Cancer
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.
Criteria for 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Memorial Sloan Kettering Cancer Center
Address:
City:
New York
Zip:
10065
Country:
United States
Status:
Recruiting
Contact:
Last name:
Neeta Pandit-Taskar, MD
Phone:
212-639-3046
Start date:
February 10, 2023
Completion date:
February 10, 2025
Lead sponsor:
Agency:
Memorial Sloan Kettering Cancer Center
Agency class:
Other
Source:
Memorial Sloan Kettering Cancer Center
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05737615
http://www.mskcc.org
