Study on FGFR2/3 Inhibitor (CGT4859) for Patients with Cholangiocarcinoma and Other Advanced Solid Tumors

Sponsor: Cogent Biosciences, Inc.

Sponsor score: 60

ClinicalTrials ID:NCT06777316

This clinical trial is testing a new drug, CGT4859, to see if it is safe and effective for adults with cholangiocarcinoma or other advanced solid tumors that have specific genetic changes in FGFR2 or FGFR3.

Patient Parameters

Program Overview

The purpose of this study is to evaluate the safety and effectiveness of a new drug called CGT4859 in adults with intrahepatic cholangiocarcinoma (iCCA) or other advanced solid tumors that have specific genetic changes in FGFR2 or FGFR3. Researchers will look at how the drug is processed in the body, its effects on the body, and its ability to fight tumors.

Eligibility Criteria

Inclusion Criteria

  • Have a confirmed diagnosis of advanced or metastatic cholangiocarcinoma or another solid tumor with specific FGFR2 or FGFR3 genetic changes.
  • Have already tried standard treatments, are not suitable for them, or have chosen not to undergo them.
  • Have at least one tumor that can be measured by scans.
  • Be in good overall health with an ECOG performance status of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
  • Have acceptable blood test results within specified limits.
  • Have recovered from any side effects of previous treatments to a mild level, except for hair loss, controlled hypothyroidism, type 1 diabetes, or nail infections managed with local treatment.

Exclusion Criteria

  • Have received chemotherapy, other cancer treatments, or radiation therapy within a certain period before starting the study drug.
  • Have had major surgery, like abdominal surgery, within 4 weeks before starting the study drug.
  • Have significant eye problems affecting the cornea or retina, or current retinal detachment.
  • Have received more than two previous treatments targeting FGFR.
  • Have active, symptomatic, or untreated brain tumors unless stable and not needing steroids for at least 2 months.

Locations

FACILITYZIPCITYSTATE
Stanford Cancer Institute94305Palo AltoCalifornia
Massachusetts General Hospital02114BostonMassachusetts
Tennessee Oncology37203NashvilleTennessee
MD Anderson Cancer Center77030HoustonTexas

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