RecruitingPhase 1Phase 2NCT06777316
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
Sponsor
Cogent Biosciences, Inc.
Enrollment
110 participants
Start Date
Jan 22, 2025
Study Type
INTERVENTIONAL
Conditions
CholangiocarcinomaAdvanced Solid TumorsIntrahepatic Cholangiocarcinoma (Icc)Other Solid Tumors, AdultFGFR2 Gene Fusion/RearrangementFGFR2 Gene AmplificationFGFR2 Gene Short VariantsFGFR3 Gene Fusion/RearrangementFGFR3 Gene AmplificationFGFR3 Gene Short VariantsFGFR2 Genetic AlterationsFGFR3 Genetic Alterations
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.
Eligibility
Min Age: 18 Years
Inclusion Criteria6
- 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.
Exclusion Criteria5
- 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.
- Clinically significant corneal or retinal disorders or current evidence of retinal detachment.
- 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.
Interventions
DRUGCGT4859
CGT4859 is a selective FGFR2/3 inhibitor
Locations(15)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06777316
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