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

Last updated: May 2, 2025
Sponsor: Cogent Biosciences, Inc.
Overall Status: Active - Recruiting

Phase

1/2

Condition

Neoplasms

Liver Cancer

Abdominal Cancer

Treatment

CGT4859

Clinical Study ID

NCT06777316
CGT4859-24-101
  • Ages > 18
  • All Genders

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.

Eligibility Criteria

Inclusion

Key Inclusion Criteria:

  1. Histologically confirmed locally advanced, metastatic, and/or unresectable iCCA orother solid tumor with documented FGFR2/3 alteration in blood and/or tumor.

  2. Previously treated with, not appropriate for, or declined standard-of-carefirst-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 chemistryand hematology) within certain limits.

  6. Resolution of toxicities from prior therapy to ≤Grade 1 (or baseline), includingresolution of clinically significant laboratory abnormalities, before the first doseof study drug. Exceptions are alopecia, hypothyroidism, or type 1 diabetes mellituscontrolled with medical intervention, and paronychia controlled with localintervention.

Exclusion

Key Exclusion Criteria:

  1. Received chemotherapy or anticancer therapies or radiotherapy within certaintimeframes before first dose of study drug.

  2. Major surgeries (eg, abdominal laparotomy) within 4 weeks of the first dose of studydrug.

  3. Clinically significant corneal or retinal disorders or current evidence of retinaldetachment.

  4. Received more than 2 prior FGFRi therapies

  5. Active, symptomatic, or untreated brain metastases unless the participant isclinically stable and off corticosteroids for ≥2 months.

Study Design

Total Participants: 110
Treatment Group(s): 1
Primary Treatment: CGT4859
Phase: 1/2
Study Start date:
January 22, 2025
Estimated Completion Date:
June 30, 2027

Connect with a study center

  • Cross Cancer Institute

    Edmonton, Alberta T6G 1Z2
    Canada

    Active - Recruiting

  • Stanford Cancer Institute

    Palo Alto, California 94305
    United States

    Active - Recruiting

  • Moffitt Cancer Center

    Tampa, Florida 33612
    United States

    Active - Recruiting

  • Massachusetts General Hospital

    Boston, Massachusetts 02114
    United States

    Active - Recruiting

  • The Christ Hospital

    Cincinnati, Ohio 45219
    United States

    Active - Recruiting

  • Taussig Cancer Center - Cleveland Clinic

    Cleveland, Ohio 44195
    United States

    Active - Recruiting

  • Fox Chase cancer Center

    Philadelphia, Pennsylvania 19111
    United States

    Active - Recruiting

  • Tennessee Oncology

    Nashville, Tennessee 37203
    United States

    Active - Recruiting

  • MD Anderson Cancer Center

    Houston, Texas 77030
    United States

    Active - Recruiting

  • Huntsman Cancer Institute - University of Utah

    Salt Lake City, Utah 84112
    United States

    Active - Recruiting

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