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

Description

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.

Conditions

Intrahepatic Cholangiocarcinoma (Icc), Cholangiocarcinoma, Other Solid Tumors, Adult, FGFR2 Gene Fusion/Rearrangement, FGFR2 Gene Amplification, FGFR2 Gene Short Variants, FGFR3 Gene Fusion/Rearrangement, FGFR3 Gene Amplification, FGFR3 Gene Short Variants, FGFR2 Genetic Alterations, FGFR3 Genetic Alterations, Advanced Solid Tumors

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Study Overview

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Study Details

Study overview

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.

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

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

Condition
Intrahepatic Cholangiocarcinoma (Icc)
Intervention / Treatment

-

Contacts and Locations

Boston

Massachusetts General Hospital, Boston, Massachusetts, United States, 02114

Nashville

Tennessee Oncology, Nashville, Tennessee, United States, 37203

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • 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. 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.
  • 5. Received more than 2 prior FGFRi therapies
  • 6. Active, symptomatic, or untreated brain metastases unless the participant is clinically stable and off corticosteroids for ≥2 months.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Cogent Biosciences, Inc.,

Study Record Dates

2027-06