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Study of Tinengotinib VS. Physician's Choice a Treatment of Subjects With FGFR-altered in Cholangiocarcinoma — FIRST-308  

Cholangiocarcinoma Clinical Trial

Official title:
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

Clinical Trial 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

Clinical Trial Description

Approximately 200 subjects will be enrolled. Eligible subjects will be randomized in a 2:2:1 ratio to receive tinengotinib 8 mg QD, tinengotinib 10 mg QD or Physician's Choice in Part A; and eligible subjects will be randomized in a 2:1 ratio to receive the recommended Part B dose or selected dose or Physician's Choice in Part B. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05948475
Study type Interventional
Source TransThera Sciences (Nanjing), Inc.
Contact Jean Fan, MD
Phone 86-25-86901107
Email fan_jean@transtherabio.com
Status Recruiting
Phase Phase 3
Start date December 20, 2023
Completion date August 2026
View Details
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