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
Latest Information Update: 05 Jul 2024
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.