Active Not RecruitingPhase 1 / Phase 2NCT06777316
Official study title

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

Study 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.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedCGT4859

The study team can explain what participation involves.

Who it may be forIntrahepatic Cholangiocarcinoma (Icc) · Cholangiocarcinoma

These are broad labels—not an eligibility decision.

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

Is enrollment open?Active Not Recruiting

The study is underway but is not accepting new participants.

What kind of study?Phase 1 / Phase 2

Interventional

Where is it offered?13 U.S. locations

Locations may change over time.

Who runs it?Cogent Biosciences, Inc.

Study sponsor

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

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion criteria

Key 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

Reasons someone may not be able to joinExclusion 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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