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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.
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

Full criteria on ClinicalTrials.gov

Sites (13)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Princess Margaret Cancer Centre - UHN
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TorontoCanadaUnknown status
Massachusetts General Hospital
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BostonUnited StatesUnknown status
University of Chicago Medicine-Comprehensive Cancer Center
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ChicagoUnited StatesUnknown status
The Christ Hospital
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CincinnatiUnited StatesUnknown status
Taussig Cancer Center - Cleveland Clinic
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ClevelandUnited StatesUnknown status
MD Anderson Cancer Center
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HoustonUnited StatesUnknown status
Mayo Clinic- Jacksonville
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JacksonvilleUnited StatesUnknown status
Tennessee Oncology
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NashvilleUnited StatesUnknown status
Stanford Cancer Institute
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Palo AltoUnited StatesUnknown status
Fox Chase Cancer Center
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PhiladelphiaUnited StatesUnknown status
Mayo Clinic - Rochester
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RochesterUnited StatesUnknown status
Huntsman Cancer Institute/University of Utah
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Salt Lake CityUnited StatesUnknown status
Moffitt Cancer Center
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TampaUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.