Trials / Active Not Recruiting
Active Not RecruitingNCT06777316
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
- Status
- Active Not Recruiting
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 110 (estimated)
- Sponsor
- Cogent Biosciences, Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
| Type | Name | Description |
|---|---|---|
| DRUG | CGT4859 | CGT4859 is a selective FGFR2/3 inhibitor |
Timeline
- Start date
- 2025-01-22
- Primary completion
- 2027-03-01
- Completion
- 2027-06-01
- First posted
- 2025-01-15
- Last updated
- 2026-04-17
Locations
13 sites across 2 countries: United States, Canada
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT06777316. Inclusion in this directory is not an endorsement.