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A Study to Evaluate KIN-3248 in Participants With Advanced Tumors Harboring FGFR2 and//or FGFR3 Gene Alterations
Trial Status: administratively complete
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK),
and preliminary efficacy of KIN-3248, an oral small molecule FGFR inhibitor, in adults
with advanced tumors harboring FGFR2 and/or FGFR3 gene alterations.
Inclusion Criteria
Provide written informed consent prior to initiation of any study-specific procedures
Advanced stage solid tumor
Known FGFR2 and/or FGFR3 gene alteration, as confirmed by previous genomic analysis of tumor tissue or ctDNA
Measurable or evaluable disease according to RECIST v1.1
ECOG performance status 0 or 1
Adequate organ function, as measured by laboratory values (criteria listed in protocol)
Able to swallow, retain, and absorb oral medications
Exclusion Criteria
Known clinically-active or clinically-progressive brain metastases from non-brain tumors
History and/or current evidence of abnormal calcium-phosphorous homeostasis, ectopic mineralization or calcification, or corneal or retinal disorder/keratopathy
GI tract disease causing an inability to take oral medication, malabsorption syndrome, requirement for intravenous alimentation, or uncontrolled inflammatory GI disease
Active, uncontrolled bacterial, fungal, or viral infection
Women who are lactating or breastfeeding, or pregnant
Additional locations may be listed on ClinicalTrials.gov for NCT05242822.
Locations matching your search criteria
United States
New York
New York
Memorial Sloan Kettering Cancer Center
Status: Active
Name Not Available
Pennsylvania
Pittsburgh
University of Pittsburgh Cancer Institute (UPCI)
Status: Active
Name Not Available
This is a two-part, open label, multi-center, dose escalation and dose expansion study in
participants with advanced tumors harboring FGFR2 and/or FGFR3 gene alterations.
Part A (dose escalation) is aimed at evaluating the safety, tolerability,
pharmacokinetics (PK), and pharmacodynamics (PD) of KIN-3248, and determining the maximum
tolerated dose (MTD) of daily dosing of KIN-3248.
Part B (dose expansion) may open once either the MTD and/or a biologically active dose of
KIN-3248 is identified. Part B is aimed at evaluating the safety and efficacy of KIN-3248
at the recommended dose and schedule in participants with cancers harboring FGFR2 and/or
FGFR3 gene alterations, including intrahepatic cholangiocarcinoma (ICC), urothelial
