A Vaccine (Ad5.F35-hGCC-PADRE) for the Treatment of Gastrointestinal Adenocarcinoma
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Pancreatic Ductal Adenocarcinoma
- Clinical Stage II Gastric Cancer AJCC v8
- Clinical Stage IIA Gastric Cancer AJCC v8
- Clinical Stage IIB Esophageal Adenocarcinoma AJCC v8
- Clinical Stage IIB Gastric Cancer AJCC v8
- Stage IIIA Colorectal Cancer AJCC v8
- Pathologic Stage IIIA Gastric Cancer AJCC v8
- Stage IA Pancreatic Cancer AJCC v8
- Stage IVB Colorectal Cancer AJCC v8
- Stage III Pancreatic Cancer AJCC v8
- Clinical Stage III Esophageal Adenocarcinoma AJCC v8
- Stage IIB Pancreatic Cancer AJCC v8
- Stage I Pancreatic Cancer AJCC v8
- Clinical Stage III Gastric Cancer AJCC v8
- Pathologic Stage III Esophageal Adenocarcinoma AJCC v8
- Stage IB Pancreatic Cancer AJCC v8
- Colorectal Adenocarcinoma
- Stage IV Colorectal Cancer AJCC v8
- Stage IIA Pancreatic Cancer AJCC v8
- Pathologic Stage IIIA Esophageal Adenocarcinoma AJCC v8
- Stage IIIB Colorectal Cancer AJCC v8
- Stage IIIC Colorectal Cancer AJCC v8
- Pathologic Stage IIIB Gastric Cancer AJCC v8
- Gastric Adenocarcinoma
- Pathologic Stage IIB Esophageal Adenocarcinoma AJCC v8
- Pathologic Stage III Gastric Cancer AJCC v8
- Stage II Pancreatic Cancer AJCC v8
- Stage III Colorectal Cancer AJCC v8
- Malignant Solid Neoplasm
- Stage IVA Colorectal Cancer AJCC v8
- Pathologic Stage IIIB Esophageal Adenocarcinoma AJCC v8
- Pathologic Stage II Gastric Cancer AJCC v8
- Pathologic Stage IIIC Gastric Cancer AJCC v8
- Pathologic Stage IIB Gastric Cancer AJCC v8
- Type
- Interventional
- Phase
- Phase 2
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
PRIMARY OBJECTIVES: I. Evaluate the safety and tolerability of sequential adenovirus 5/F35-human guanylyl cyclase C-PADRE (Ad5.F35-hGCC-PADRE), delivered intramuscularly three times at three dose levels in subjects with high-risk colorectal, pancreatic, gastric, or esophageal adenocarcinomas with no...
PRIMARY OBJECTIVES: I. Evaluate the safety and tolerability of sequential adenovirus 5/F35-human guanylyl cyclase C-PADRE (Ad5.F35-hGCC-PADRE), delivered intramuscularly three times at three dose levels in subjects with high-risk colorectal, pancreatic, gastric, or esophageal adenocarcinomas with no evidence of disease (NED) after surgery and standard therapy. II. Evaluate the cellular (T-cell) responses to Ad5.F35-hGCC-PADRE at three different dose levels (10^11, 10^12, and 5 x 10^12 vp) administered intramuscularly three times, four weeks apart in subjects with high-risk colorectal, pancreatic, gastric, or esophageal cancer with NED after surgery and standard therapy. EXPLORATORY OBJECTIVES: I. Evaluate the humoral immunologic response to guanylyl cyclase C (GCC), defined as an incremental or sustained antibody (pan-Ig) response, measured at weeks 5, 9, and 13 following the first vaccination (week 1). II. Evaluate the relationship between immunological responses to GCC and 1) neutralizing antibodies to Ad5 and Ad5.F35 and 2) GCC protein expression in tumors to assess immune tolerance. III. Evaluate disease free survival (DFS) and overall survival (OS), where feasible. OUTLINE: Patients are randomized to 1 of 3 arms. ARM A: Patients receive low dose Ad5.F35-hGCC-PADRE vaccine intramuscularly (IM) on day 1 of weeks 1, 5, and 9 in the absence of disease progression or unacceptable toxicity. ARM B: Patients receive medium dose Ad5.F35-hGCC-PADRE vaccine IM on day 1 of weeks 1, 5, and 9 in the absence of disease progression or unacceptable toxicity. ARM C: Patients receive high dose Ad5.F35-hGCC-PADRE vaccine IM on day 1 of weeks 1, 5, and 9 in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up at 28 days, and then every 3 months for at least 24 months.
Tracking Information
- NCT #
- NCT04111172
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Babar Bashir, MD Sidney Kimmel Cancer Center at Thomas Jefferson University