A Study to Evaluate KIN-3248 in Participants With Advanced Tumors Harboring FGFR2 and//or FGFR3 Gene Alterations

• Status: Not yet recruiting
• Trial end date: 2026-09-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Kinnate Biopharma

Criteria

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