OncoMatch/Clinical Trials/NCT05948475
Study of Tinengotinib VS. Physician's Choice a Treatment of Subjects With FGFR-altered in Cholangiocarcinoma
Is NCT05948475 recruiting? Yes, currently enrolling (Jun 2026). This Phase 3 trial studies multiple treatments including Tinengotinib 8 mg and Tinengotinib 10 mg for cholangiocarcinoma.
Treatment: Tinengotinib 8 mg · Tinengotinib 10 mg · Physician's Choice — 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
Check if I qualifyExtracted eligibility criteria
Treatments studied
Other
Cancer type
Cholangiocarcinoma
Biomarker criteria
Required: FGFR2 fusion/rearrangement
Prior therapy
Must have received: chemotherapy
Subjects must have received at least one line of prior chemotherapy
Must have received: FGFR inhibitor
exactly one FDA approved FGFR inhibitor
Cannot have received: FGFR inhibitor
Prior receipt of two or more FGFR inhibitors, either approved or investigational drugs
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- UCLA Medical Center · Santa Monica, California
- Stanford Cancer Center · Stanford, California
- The University of Kansas Cancer Center · Westwood, Los Angeles, California
- Mount Sinai Comprehensive Cancer Center · Miami Beach, Florida
- The University of Chicago Hospitals · Chicago, Illinois
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT05948475 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior FGFR inhibitor disqualifies patients from enrollment.
Does this trial require FGFR2?
Yes, FGFR2 fusion/rearrangement is a required biomarker for enrollment.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages