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A Phase III, Randomized, Controlled, Global Multicenter Study to Evaluate the Efficacy and Safety of Oral Tinengotinib VS Physician's Choice in Subjects With FGFR-altered, Chemotherapy- and FGFR Inhibitor-Cholangiocarcinoma

Trial Profile

A Phase III, Randomized, Controlled, Global Multicenter Study to Evaluate the Efficacy and Safety of Oral Tinengotinib VS Physician's Choice in Subjects With FGFR-altered, Chemotherapy- and FGFR Inhibitor-Cholangiocarcinoma

Status: Recruiting
Phase of Trial: Phase III

Latest Information Update: 05 Jul 2024

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At a glance

  • Drugs Tinengotinib (Primary) ; Fluorouracil; Folinic acid; Irinotecan; Oxaliplatin
  • Indications Adenocarcinoma; Cholangiocarcinoma
  • Focus Adverse reactions; Registrational; Therapeutic Use
  • Acronyms FIRST-308
  • Sponsors TransThera Biosciences

Most Recent Events

  • 08 Mar 2024 According to a TransThera Biosciences media release, company announced that the FIRST-308 study has been authorized by regulatory agencies in the European Union (EU) after the authorizations from US, South Korea and Taiwan region.
  • 20 Jan 2024 Study design presented at the 2024 Gastrointestinal Cancers Symposium.
  • 21 Dec 2023 According to a TransThera media release, this study is planned to be conducted in the US, the EU, the UK, Asia, and other countries and regions, and the final results will support a global marketing application for tinengotinib.

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