Status:
TERMINATED
A Study to Evaluate KIN-3248 in Participants With Advanced Tumors Harboring FGFR2 and//or FGFR3 Gene Alterations
Lead Sponsor:
Kinnate Biopharma
Conditions:
Solid Tumor, Adult
Intrahepatic Cholangiocarcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief 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 ha...
Detailed Description
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 ...
Eligibility Criteria
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
- 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
Key Trial Info
Start Date :
March 29 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 3 2024
Estimated Enrollment :
54 Patients enrolled
Trial Details
Trial ID
NCT05242822
Start Date
March 29 2022
End Date
October 3 2024
Last Update
May 7 2025
Active Locations (21)
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1
Mayo Clinic Arizona
Phoenix, Arizona, United States, 85054
2
UC San Diego Moores Cancer Center
La Jolla, California, United States, 92093
3
Mayo Clinic Florida
Jacksonville, Florida, United States, 32224
4
Sarah Cannon Research Institute - Lake Nona
Orlando, Florida, United States, 32827