A Study of an FGFR2/3 Inhibitor (CGT4859) in Patients With Cholangiocarcinoma and Other Advanced Solid Tumors
NCT ID: NCT06777316
Last Updated: 2025-07-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1/PHASE2
110 participants
INTERVENTIONAL
2025-01-22
2027-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
Phase 2 will evaluate the RP2D in 4 cohorts defined by tumor type and prior therapy based on Phase 1 results.
TREATMENT
NONE
Study Groups
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Phase 1: Dose Escalation
Multiple doses of CGT4859 for oral administration
CGT4859
CGT4859 is a selective FGFR2/3 inhibitor
Phase 2: Signal Seeking
Oral dose of CGT4859 at the RP2D as determined in Phase 1
CGT4859
CGT4859 is a selective FGFR2/3 inhibitor
Interventions
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CGT4859
CGT4859 is a selective FGFR2/3 inhibitor
Eligibility Criteria
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Inclusion Criteria
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.
6. 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.
Exclusion Criteria
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. Received more than 2 prior FGFRi therapies
5. Active, symptomatic, or untreated brain metastases unless the participant is clinically stable and off corticosteroids for ≥2 months.
18 Years
ALL
No
Sponsors
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Cogent Biosciences, Inc.
INDUSTRY
Responsible Party
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Locations
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Mayo Clinic Scottsdale
Scottsdale, Arizona, United States
Stanford Cancer Institute
Palo Alto, California, United States
Mayo Clinic Jacksonville
Jacksonville, Florida, United States
Moffitt Cancer Center
Tampa, Florida, United States
University of Chicago Medicine Comprehensive Cancer Center
Chicago, Illinois, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Mayo Clinic Rochester
Rochester, Minnesota, United States
The Christ Hospital
Cincinnati, Ohio, United States
Taussig Cancer Center - Cleveland Clinic
Cleveland, Ohio, United States
Fox Chase cancer Center
Philadelphia, Pennsylvania, United States
Tennessee Oncology
Nashville, Tennessee, United States
MD Anderson Cancer Center
Houston, Texas, United States
Huntsman Cancer Institute - University of Utah
Salt Lake City, Utah, United States
Cross Cancer Institute
Edmonton, Alberta, Canada
Princess Margaret Cancer Centre - UHN
Toronto, Ontario, Canada
Countries
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Central Contacts
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Other Identifiers
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CGT4859-24-101
Identifier Type: -
Identifier Source: org_study_id
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