Clinical Trial

Study of Tinengotinib VS. Physician's Choice a Treatment of Subjects With FGFR-altered in Cholangiocarcinoma

Study acronym: FIRST-308
Active, Not Recruiting Phase 3
View on ClinicalTrials.gov →
Summary
This study is a Phase III, Randomized, Controlled, Global Multicenter Study to Evaluate the Efficacy and Safety of Oral Tinengotinib versus Physician's Choice in Subjects with Fibroblast Growth Factor Receptor (FGFR)-altered, Chemotherapy- and FGFR Inhibitor-Refractory/Relapsed Cholangiocarcinoma
Protocol Amendment History 21 amendments
This ClinicalTrials.gov record has been amended 21 times since 2023-07-07; most recent amendment 2026-07-01.
Status change: Recruiting → Active, Not Recruiting 2026-07-01
Status change: Not Yet Recruiting → Recruiting 2023-12-05
Trial Details
NCT Number NCT05948475
Lead Sponsor TransThera Sciences (Nanjing), Inc.
Conditions Cholangiocarcinoma
Enrollment 200 participants
Start Date 2023-12-20
Primary Completion 2026-12 (estimated)
Study Completion 2026-12 (estimated)
Updated on ClinicalTrials.gov 2026-07-06