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

StatusActive, Not Recruiting
PhasePhase 1/2
Started
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Record History

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  1. Minor Trial status: Recruiting to Active, Not Recruiting
    • Study sites: 15 to 13
    v8
  2. Minor Study sites: 10 to 15v7
  3. Minor Study sites: 8 to 10v6
  4. Minor Study sites: 4 to 8v5
  5. Minor Study sites: 3 to 4
    • Start date changed from estimate of Jan 2025 to Jan 22, 2025
    v4
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  1. Minor Eligibility criteria revisedv3
  2. Minor Study sites: 2 to 3v2
  1. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06777316
Lead Sponsor Cogent Biosciences, Inc.
Conditions
(from sponsor)
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
Related terms Cholangiocarcinoma, Cirrhosis, Familial, with Pulmonary Hypertension
Enrollment 110 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov