A Vaccine (Ad5.F35-hGCC-PADRE) for the Treatment of Gastrointestinal Adenocarcinoma
Public ClinicalTrials.gov record NCT04111172. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase 2A/2B, Dose-Finding and Expansion Study of Ad5.F35-hGCC-PADRE Vaccine in Adults With Gastrointestinal Adenocarcinomas at Risk of Relapse Post Definitive Surgery and Standard Therapy
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This is an open-label, dose-finding, Phase 2A/2B study of Ad5.F35-hGCC-PADRE as a vaccine for gastrointestinal (GI) malignancies (pancreatic, colorectal, esophageal, gastric, and small bowel adenocarcinomas) who have received surgical resection and standard adjuvant therapy. In Phase 2A, patients will be given multiple administrations of Ad5.F35-hGCC-PADRE intramuscularly at 1 of 3 dose levels. Treatment-related toxicity and development of immune responses to GCC will be evaluated at Weeks 5, 9, and 13 after the initial vaccination (Week 1). Primary safety endpoints will examine adverse events (AEs), injection-site reactions and clinically-significant changes in safety laboratory tests. Primary efficacy endpoints include the development of GCC-specific T-cell responses at different dose levels (1011, 1012, and 5x1012 virus particles or vp). In Phase 2B Dose Expansion cohort, a group of 20 colon cancer patients who are ctDNA+ by CLIA-certified standard of care assays will receive a single administration of Ad5.F35-hGCC-PADRE vaccine intramuscularly at prespecified dose of 1012 vp. Phase 2b is NOT randomized. Primary safety endpoints will examine AEs, injection-site reactions and clinically significant changes in safety laboratory tests. The primary efficacy endpoints include GCC-specific T-cell responses at 1012 vp in ctDNA+ patients. Additional exploratory endpoint will determine elimination of minimal residual disease (MRD) by ctDNA clearance.
Study identification
- NCT ID
- NCT04111172
- Recruitment status
- Suspended
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 48 participants
Conditions and interventions
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
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Nov 10, 2020 (Actual)
- Primary completion
- Apr 2028 (Estimated)
- Completion
- Apr 2028 (Estimated)
- Last update posted
- Sep 14, 2026
2020 – 2028
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Sidney Kimmel Cancer Center at Thomas Jefferson University | Philadelphia | Pennsylvania | 19107 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04111172, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Sep 14, 2026 · Synced Oct 24, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT04111172 live on ClinicalTrials.gov.