A Study to Evaluate KIN-3248 in Participants With Advanced Tumors Harboring FGFR2 and//or FGFR3 Gene Alterations
Megadott ok: Due to a change in the Sponsor's corporate strategy the study was terminated early by the Sponsor prior to enrollment into the dose expansion part of the study (Part B).
Key facts
- Where
- Boston, Grand Rapids, Houston, Jacksonville, La Jolla, Madison, Nashville, New York, Orlando, Philadelphia, Phoenix és Rochester, Egyesült ÁllamokSee the 12 sites
- Phase
- 1. fázis
Where in Egyesült Államok
- Massachusetts General HospitalBoston, Egyesült ÁllamokNo longer taking part
- START | MidwestGrand Rapids, Egyesült ÁllamokNo longer taking part
- MD Anderson Cancer CenterHouston, Egyesült ÁllamokNo longer taking part
- Mayo Clinic FloridaJacksonville, Egyesült ÁllamokNo longer taking part
- UC San Diego Moores Cancer CenterLa Jolla, Egyesült ÁllamokNo longer taking part
- University of Wisconsin Carbone Cancer CenterMadison, Egyesült ÁllamokNo longer taking part
- Sarah Cannon Research InstituteNashville, Egyesült ÁllamokNo longer taking part
- NYU Langone Cancer CenterNew York, Egyesült ÁllamokNo longer taking part
- Sarah Cannon Research Institute (Lake Nona)Orlando, Egyesült ÁllamokNo longer taking part
- Fox Chase Cancer CenterPhiladelphia, Egyesült ÁllamokNo longer taking part
- Mayo Clinic - ArizonaPhoenix, Egyesült ÁllamokNo longer taking part
- Mayo Clinic - RochesterRochester, Egyesült ÁllamokNo longer taking part
Trial details
- Who runs it
- Kinnate Biopharma
- Trial code
- NCT05242822
- Record updated
- 2025. május 7.
- Original description
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.Read full original descriptionShow less
A Phase 1/1b, Open-label, Multicenter Study to Investigate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Anti-tumor Activity of KIN-3248 in Participants With Advanced Tumors Harboring FGFR2 and/or FGFR3 Gene Alterations
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: 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: 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; History and/or current evidence of abnormal calcium-phosphorous homeostasis, ectopic mineralization or calcification, or corneal or retinal disorder/keratopathy; Known clinically-active or clinically-progressive brain metastases from non-brain tumors; Women who are lactating or breastfeeding, or pregnant.