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drugset / Trial / NCT05948475

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

NCT05948475 ↗

Phase 3 Active not recruiting 200 enrolled TransThera Sciences (Nanjing), Inc.
RandomizedParallel-groupOpen-labelTreatment

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

Timeline

Start
2023-12-20
Primary completion
2026-12
Completion
2026-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Tinengotinib Small molecule 8 mg Oral
Subject Tinengotinib Small molecule 10 mg Oral

Indications

cholangiocarcinoma