Clinical Trial

A Study of an FGFR2/3 Inhibitor (CGT4859) in Patients With Cholangiocarcinoma and Other Advanced Solid Tumors

Active, Not Recruiting Phase 1/2
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Summary
This is an open-label, phase 1/2 study evaluating the safety, tolerability, pharmacokinetic (what the body does to the drug), pharmacodynamic (what the drug does to the body), and antitumor activity of CGT4859 in adult participants with intrahepatic cholangiocarcinoma (iCCA) or other advanced solid tumors with FGFR2 and/or FGFR3 genetic alternations.
Protocol Amendment History 7 amendments
This ClinicalTrials.gov record has been amended 7 times since 2025-01-10; most recent amendment 2026-04-15.
Status change: Recruiting → Active, Not Recruiting 2026-04-15
Trial Details
NCT Number NCT06777316
Lead Sponsor Cogent Biosciences, Inc.
Conditions Intrahepatic Cholangiocarcinoma (Icc), Cholangiocarcinoma, Other Solid Tumors, Adult, FGFR2 Gene Fusion/Rearrangement, FGFR2 Gene Amplification, FGFR2 Gene Short Variants, FGFR3 Gene Fusion/Rearrangement, FGFR3 Gene Amplification +4 more
Enrollment 110 participants
Start Date 2025-01-22
Primary Completion 2027-03 (estimated)
Study Completion 2027-06 (estimated)
Updated on ClinicalTrials.gov 2026-04-17