RecruitingPhase 1Phase 2NCT06777316

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

A Phase 1/2 Study of a Selective FGFR2/3 Inhibitor, CGT4859, in Patients With Cholangiocarcinoma and Other Advanced Solid Tumors Harboring FGFR2 and/or FGFR3 Genetic Alterations


Sponsor

Cogent Biosciences, Inc.

Enrollment

110 participants

Start Date

Jan 22, 2025

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This is an early-phase clinical trial testing a new targeted drug called CGT4859 in patients with a type of bile duct cancer (cholangiocarcinoma) or other advanced cancers that have a specific genetic change in the FGFR2 or FGFR3 genes. The goal is to find out if this drug is safe and whether it can shrink tumors in these patients. **You may be eligible if...** - You have advanced, metastatic, or inoperable bile duct cancer (intrahepatic cholangiocarcinoma) or another solid tumor - Your tumor has been confirmed to have an FGFR2 or FGFR3 genetic alteration - You have already received standard treatment, or standard treatment is not appropriate for you - Your cancer is measurable on scans - You have a good general performance status (able to carry out daily activities) - You are 18 years of age or older **You may NOT be eligible if...** - Your cancer has not been tested for FGFR2/3 alterations or does not have these changes - You have significant unresolved side effects from prior treatments - You have certain heart, eye, or other organ conditions that could be worsened by this drug Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGCGT4859

CGT4859 is a selective FGFR2/3 inhibitor


Locations(15)

Mayo Clinic Scottsdale

Scottsdale, Arizona, United States

Stanford Cancer Institute

Palo Alto, California, United States

Mayo Clinic Jacksonville

Jacksonville, Florida, United States

Moffitt Cancer Center

Tampa, Florida, United States

University of Chicago Medicine Comprehensive Cancer Center

Chicago, Illinois, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

Mayo Clinic Rochester

Rochester, Minnesota, United States

The Christ Hospital

Cincinnati, Ohio, United States

Taussig Cancer Center - Cleveland Clinic

Cleveland, Ohio, United States

Fox Chase cancer Center

Philadelphia, Pennsylvania, United States

Tennessee Oncology

Nashville, Tennessee, United States

MD Anderson Cancer Center

Houston, Texas, United States

Huntsman Cancer Institute - University of Utah

Salt Lake City, Utah, United States

Cross Cancer Institute

Edmonton, Alberta, Canada

Princess Margaret Cancer Centre - UHN

Toronto, Ontario, Canada

View Full Details on ClinicalTrials.gov

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NCT06777316


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