Metastatic Pancreatic Cancer, Metastatic Pancreatic Ductal Adenocarcinoma, Pancreatic Cancer, Pancreatic Ductal Adenocarcinoma, Primary Pancreatic Ductal Adenocarcinoma
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
Brief 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.
Interventions
DIAGNOSTIC_TESTPET Scan
Participants will be imaged up to 4 time points post-injection to allow for biodistribution and dosimetry determination
DRUGhu5B1-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.
DRUG64Cu-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_TESTPharmacokinetics
All participants receiving 64Cu-Tz-SarAr will have serial blood samples drawn.
Sponsors
Memorial Sloan Kettering Cancer Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| SUV mean measurement | 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 |
Contacts
PRINCIPAL_INVESTIGATORSomali Gavane, MD
Memorial Sloan Kettering Cancer Center
Outcome results
None listed