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

NCT06777316 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 110

Last updated 2026-04-17

No results posted yet for this 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.

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

Interventions

DRUG

CGT4859

CGT4859 is a selective FGFR2/3 inhibitor

Sponsors & Collaborators

  • Cogent Biosciences, Inc.

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-01-22
Primary Completion
2027-03-31
Completion
2027-06-30
FDA Drug
Yes

Countries

  • United States
  • Canada

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06777316 on ClinicalTrials.gov