A Phase 2A, Dose-Finding Study of Ad5.F35-hGCC-PADRE Vaccine in Adults With Gastrointestinal Adenocarcinomas at Risk of Relapse Post Definitive Surgery and Standard Therapy

Status: Suspended

Phase of Trial: Phase II

Latest Information Update: 15 May 2024

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At a glance

Drugs Ad5.F35 hGCC PADRE (Primary)
Indications Adenocarcinoma; Colorectal cancer; Ductal carcinoma; Gastric cancer; Oesophageal cancer; Pancreatic cancer
Focus Adverse reactions; Pharmacodynamics

09 May 2024 Planned primary completion date changed from 20 Mar 2024 to 1 Jul 2024.
31 Jan 2024 Status changed to suspended.
20 Jan 2024 According to trial design presented at the 2024 Gastrointestinal Cancers Symposium An interim futility analysis will be performed after 15 patients have completed treatment in each arm based on the Simon minimax design.Prespecified safety run-in has been completed without dose limiting toxicities; second stage accrual began in November 2021, and 43 out of 81 pts have been enrolled.

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