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A Phase 3, Randomized, Double-blind, Placebo-controlled Study Evaluating Combination of TST001, Nivolumab and Chemotherapy as First-Line Treatment in Subjects With Claudin18.2 Positive Locally Advanced or Metastatic Gastric or Gastroesophageal Junction (Gastric/GEJ) Adenocarcinoma

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Trial Profile

A Phase 3, Randomized, Double-blind, Placebo-controlled Study Evaluating Combination of TST001, Nivolumab and Chemotherapy as First-Line Treatment in Subjects With Claudin18.2 Positive Locally Advanced or Metastatic Gastric or Gastroesophageal Junction (Gastric/GEJ) Adenocarcinoma

Status: Not yet recruiting
Phase of Trial: Phase III

Latest Information Update: 10 Apr 2024

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At a glance

  • Drugs Nivolumab (Primary) ; Osemitamab (Primary) ; Antineoplastics
  • Indications Adenocarcinoma; Gastric cancer; Oesophageal cancer
  • Focus Registrational; Therapeutic Use
  • Acronyms TranStar301
  • Sponsors Transcenta Holding

Most Recent Events

  • 08 Apr 2024 According to Transcenta Holding media release, company announced a Collaboration with Agilent to develop a Claudin18.2 (CLDN18.2) companion diagnostic to support this study. Claudin18.2 IHC 14G11 pharmDx for Investigational Use Only/for Performance Evaluation Only will be used for patient selection in the phase III trial of gastric/GEJ adenocarcinoma where applicable ethics committee and regulatory approvals have been granted.
  • 16 Oct 2023 Status changed from planning to not yet recruiting.
  • 04 Oct 2023 According to Transcenta Holding media release, the FDA has granted clearance to proceed with this trial.

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