NCT04111172

A Vaccine (Ad5.F35-hGCC-PADRE) for the Treatment of Gastrointestinal Adenocarcinoma

Active, enrolled Phase 2 Last updated 22 August 2025

What this trial tests

Phase 2 trial testing Adenovirus 5/F35-Human Guanylyl Cyclase C-PADRE in Pancreatic Ductal Adenocarcinoma in 48 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

10 November 2020

Primary endpoint
1 March 2026

1 March 2027

Quick facts

Lead sponsor	Thomas Jefferson University
Phase	Phase 2
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	48
Start date	10 November 2020
Primary completion	1 March 2026
Estimated completion	1 March 2027
Sites	1 location across United States

Drugs / interventions tested

• Adenovirus 5/F35-Human Guanylyl Cyclase C-PADRE — full drug profile →

Conditions studied

• Pancreatic Ductal Adenocarcinoma — all drugs for Pancreatic Ductal Adenocarcinoma →
• Colorectal Adenocarcinoma — all drugs for Colorectal Adenocarcinoma →
• Gastric Adenocarcinoma — all drugs for Gastric Adenocarcinoma →
• Clinical Stage II Gastric Cancer AJCC v8 — all drugs for Clinical Stage II Gastric Cancer AJCC v8 →

Sponsor

Thomas Jefferson University

Who can join

18 and older, any sex, with Pancreatic Ductal Adenocarcinoma or Colorectal Adenocarcinoma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Cancer vaccines as promising immuno-therapeutics: platforms and current progress.
   Liu J, Fu M, Wang M, Wan D, et al · · 2022 · cited 497× · PMID 35303904 · DOI 10.1186/s13045-022-01247-x
2. Colorectal cancer vaccines: The current scenario and future prospects.
   Jia W, Zhang T, Huang H, Feng H, et al · · 2022 · cited 33× · PMID 35990683 · DOI 10.3389/fimmu.2022.942235
3. Chimeric Ad5.F35 vector evades anti-adenovirus serotype 5 neutralization opposing GUCY2C-targeted antitumor immunity.
   Flickinger JC, Singh J, Carlson R, Leong E, et al · · 2020 · cited 26× · PMID 32819976 · DOI 10.1136/jitc-2020-001046
4. Mirage or long-awaited oasis: reinvigorating T-cell responses in pancreatic cancer.
   Ware MB, El-Rayes BF, Lesinski GB. · · 2020 · cited 24× · PMID 32843336 · DOI 10.1136/jitc-2020-001100
5. Evolving Horizons: Adenovirus Vectors' Timeless Influence on Cancer, Gene Therapy and Vaccines.
   Trivedi PD, Byrne BJ, Corti M. · · 2023 · cited 22× · PMID 38140619 · DOI 10.3390/v15122378
6. Next-generation immunotherapy for pancreatic ductal adenocarcinoma: navigating pathways of immune resistance.
   Heumann T, Azad N. · · 2021 · cited 17× · PMID 34591243 · DOI 10.1007/s10555-021-09981-3
7. Guanylyl cyclase 2C (GUCY2C) in gastrointestinal cancers: recent innovations and therapeutic potential.
   Entezari AA, Snook AE, Waldman SA. · · 2021 · cited 14× · PMID 34056991 · DOI 10.1080/14728222.2021.1937124
8. GUCY2C as a biomarker to target precision therapies for patients with colorectal cancer.
   Lisby AN, Flickinger JC, Bashir B, Weindorfer M, et al · · 2021 · cited 13× · PMID 34027103 · DOI 10.1080/23808993.2021.1876518