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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

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Trial Profile

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: 13 Mar 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

    • Most Recent Events

    • 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.
    • 20 Jan 2024 Trial design presented at the 2024 Gastrointestinal Cancers Symposium.
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