A Vaccine (Ad5.F35-hGCC-PADRE) for the Treatment of Gastrointestinal Adenocarcinoma
NCT04111172 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 48
Last updated 2025-08-22
Summary
This phase IIA trial investigates the side effects of Ad5.F35-hGCC-PADRE vaccine and to see how well it works in treating patients with gastrointestinal adenocarcinoma. Ad5.F35-hGCC-PADRE vaccine may help to train the patient's own immune system to identify and kill tumor cells and prevent it from coming back.
Conditions
- Pancreatic Ductal Adenocarcinoma
- Colorectal Adenocarcinoma
- Gastric 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
- Clinical Stage III Esophageal Adenocarcinoma AJCC v8
- Clinical Stage III Gastric Cancer AJCC v8
- Malignant Solid Neoplasm
- Pathologic Stage II Gastric Cancer AJCC v8
- Pathologic Stage IIB Esophageal Adenocarcinoma AJCC v8
- Pathologic Stage IIB Gastric Cancer AJCC v8
- Pathologic Stage III Esophageal Adenocarcinoma AJCC v8
- Pathologic Stage III Gastric Cancer AJCC v8
- Pathologic Stage IIIA Esophageal Adenocarcinoma AJCC v8
- Pathologic Stage IIIB Esophageal Adenocarcinoma AJCC v8
- Pathologic Stage IIIA Gastric Cancer AJCC v8
- Pathologic Stage IIIB Gastric Cancer AJCC v8
- Pathologic Stage IIIC Gastric Cancer AJCC v8
- Stage I Pancreatic Cancer AJCC v8
- Stage IA Pancreatic Cancer AJCC v8
- Stage IB Pancreatic Cancer AJCC v8
- Stage II Pancreatic Cancer AJCC v8
- Stage IIA Pancreatic Cancer AJCC v8
- Stage IIB Pancreatic Cancer AJCC v8
- Stage III Colorectal Cancer AJCC v8
- Stage III Pancreatic Cancer AJCC v8
- Stage IIIA Colorectal Cancer AJCC v8
- Stage IIIB Colorectal Cancer AJCC v8
- Stage IIIC Colorectal Cancer AJCC v8
- Stage IV Colorectal Cancer AJCC v8
- Stage IVA Colorectal Cancer AJCC v8
- Stage IVB Colorectal Cancer AJCC v8
- Malignant Digestive System Neoplasm
- Small Intestinal Adenocarcinoma
- Stage III Small Intestinal Adenocarcinoma AJCC v8
- Stage IIIA Small Intestinal Adenocarcinoma AJCC v8
Interventions
- BIOLOGICAL
-
Adenovirus 5/F35-Human Guanylyl Cyclase C-PADRE
Given as intramuscular injection
Sponsors & Collaborators
-
Thomas Jefferson University
lead OTHER
Principal Investigators
-
Babar Bashir, MD · Sidney Kimmel Cancer Center at Thomas Jefferson University
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2020-11-10
- Primary Completion
- 2026-03-01
- Completion
- 2027-03-01
- FDA Drug
- Yes
Countries
- United States
Study Locations
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