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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 (May 2026). This Phase 3 trial studies multiple treatments including Tinengotinib 8 mg and Tinengotinib 10 mg for cholangiocarcinoma.

Phase 3RecruitingTransThera Sciences (Nanjing), Inc.NCT05948475Data as of May 2026

Treatment: Tinengotinib 8 mg · Tinengotinib 10 mg · Physician's ChoiceThis 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

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Extracted eligibility criteria

Cancer type

Cholangiocarcinoma

Biomarker criteria

Required: FGFR2 fusion/rearrangement

Prior therapy

Min 2 prior lines

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 →

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