NCT06777316Active, not recruitingPhase 1/2
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
Source: ClinicalTrials.gov · Last updated 17 Apr 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 110 (estimated)
- First submitted
- 9 Jan 2025
- Start date
- 22 Jan 2025
- Primary completion date
- Mar 2027
- Lead sponsor
- Cogent Biosciences, Inc.
- Diseases
- Liver and biliary tract cancer
- NCT number
- NCT06777316
What you commit to
- Study type: Interventional · Phase 1/2
- Planned participants: 110
- From 22 Jan 2025 to the primary completion date, Mar 2027
- 13 sites in 2 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Received chemotherapy or anticancer therapies or radiotherapy within certain timeframes before first dose of study drug.
- Major surgeries (eg, abdominal laparotomy) within 4 weeks of the first dose of study drug.
- Received more than 2 prior FGFRi therapies
- Active, symptomatic, or untreated brain metastases unless the participant is clinically stable and off corticosteroids for ≥2 months.
Other illness
- Clinically significant corneal or retinal disorders or current evidence of retinal detachment.
Who the study is looking for
- Histologically confirmed locally advanced, metastatic, and/or unresectable iCCA or other solid tumor with documented FGFR2/3 alteration in blood and/or tumor.
- Previously treated with, not appropriate for, or declined standard-of-care first-line treatment.
- Have measurable disease per RECIST v1.1.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
- Have clinically acceptable local laboratory screening results (clinical chemistry and hematology) within certain limits.
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (13)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Princess Margaret Cancer Centre - UHN Coordinator of this site? Confirm its status | Toronto | Canada | Unknown status |
| Massachusetts General Hospital Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
| University of Chicago Medicine-Comprehensive Cancer Center Coordinator of this site? Confirm its status | Chicago | United States | Unknown status |
| The Christ Hospital Coordinator of this site? Confirm its status | Cincinnati | United States | Unknown status |
| Taussig Cancer Center - Cleveland Clinic Coordinator of this site? Confirm its status | Cleveland | United States | Unknown status |
| MD Anderson Cancer Center Coordinator of this site? Confirm its status | Houston | United States | Unknown status |
| Mayo Clinic- Jacksonville Coordinator of this site? Confirm its status | Jacksonville | United States | Unknown status |
| Tennessee Oncology Coordinator of this site? Confirm its status | Nashville | United States | Unknown status |
| Stanford Cancer Institute Coordinator of this site? Confirm its status | Palo Alto | United States | Unknown status |
| Fox Chase Cancer Center Coordinator of this site? Confirm its status | Philadelphia | United States | Unknown status |
| Mayo Clinic - Rochester Coordinator of this site? Confirm its status | Rochester | United States | Unknown status |
| Huntsman Cancer Institute/University of Utah Coordinator of this site? Confirm its status | Salt Lake City | United States | Unknown status |
| Moffitt Cancer Center Coordinator of this site? Confirm its status | Tampa | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.