Active Not RecruitingPhase 1 / Phase 2NCT06777316

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

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.

Checked against the public recordLast updated Apr 17, 2026 · Source: ClinicalTrials.gov

StatusActive Not Recruiting
PhasePhase 1 / Phase 2
U.S. locations13
SponsorCogent Biosciences, Inc.
01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 1 / Phase 2
Sponsor
Cogent Biosciences, Inc.
Interventions being studied
Drug: CGT4859
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

03
Public criteria

Who may be able to participate

Key Inclusion Criteria: 1. Histologically confirmed locally advanced, metastatic, and/or unresectable iCCA or other solid tumor with documented FGFR2/3 alteration in blood and/or tumor. 2. Previously treated with, not appropriate for, or declined standard-of-care first-line treatment. 3. Have measurable disease per RECIST v1.1. 4. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1. 5. Have clinically acceptable local laboratory screening results (clinical chemistry and hematology) within certain limits. 6. Resolution of toxicities from prior therapy to ≤Grade 1 (or baseline), including resolution of clinically significant laboratory abnormalities, before the first dose of study drug. Exceptions are alopecia, hypothyroidism, or type 1 diabetes mellitus controlled with medical intervention, and paronychia controlled with local intervention. Key Exclusion Criteria: 1. Received chemotherapy or anticancer therapies or radiotherapy within certain timeframes before first dose of study drug. 2. Major surgeries (eg, abdominal laparotomy) within 4 weeks of the first dose of study drug. 3. Clinically significant corneal or retinal disorders or current evidence of retinal detachment. 4. Received more than 2 prior FGFRi therapies 5. Active, symptomatic, or untreated brain metastases unless the participant is clinically stable and off corticosteroids for ≥2 months.

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • Stanford Cancer InstitutePalo Alto, California
  • Mayo Clinic JacksonvilleJacksonville, Florida
  • Moffitt Cancer CenterTampa, Florida
  • University of Chicago Medicine Comprehensive Cancer CenterChicago, Illinois
  • Massachusetts General HospitalBoston, Massachusetts
  • Mayo Clinic RochesterRochester, Minnesota
  • The Christ HospitalCincinnati, Ohio
  • Taussig Cancer Center - Cleveland ClinicCleveland, Ohio
  • Fox Chase cancer CenterPhiladelphia, Pennsylvania
  • Tennessee OncologyNashville, Tennessee
  • MD Anderson Cancer CenterHouston, Texas
  • Huntsman Cancer Institute - University of UtahSalt Lake City, Utah

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Apr 17, 2026. Always confirm current availability with the study team.

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