A Study to Evaluate KIN-3248 in Participants With Advanced Tumors Harboring FGFR2 and//or FGFR3 Gene Alterations
NCT ID: NCT05242822
Last Updated: 2025-05-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE1
54 participants
INTERVENTIONAL
2022-03-29
2024-10-03
Brief Summary
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Detailed Description
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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 cancer (UC), and other solid tumors.
Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Part A - dose escalation
Dose escalation of KIN-3248 in patients with solid tumors
KIN-3248
KIN-3248 will be administered orally once daily in 28-day cycles
Part B - dose expansion
Dose expansion evaluating the recommended dose and schedule of KIN-3248 identified from Part A
KIN-3248
KIN-3248 will be administered orally once daily in 28-day cycles
Interventions
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KIN-3248
KIN-3248 will be administered orally once daily in 28-day cycles
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Kinnate Biopharma
INDUSTRY
Responsible Party
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Locations
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Mayo Clinic Arizona
Phoenix, Arizona, United States
UC San Diego Moores Cancer Center
La Jolla, California, United States
Mayo Clinic Florida
Jacksonville, Florida, United States
Sarah Cannon Research Institute - Lake Nona
Orlando, Florida, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
START Midwest
Grand Rapids, Michigan, United States
Mayo Clinic Rochester
Rochester, Minnesota, United States
NYU Langone Cancer Center
New York, New York, United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States
Sarah Cannon Research Institute
Nashville, Tennessee, United States
MD Anderson Cancer Center
Houston, Texas, United States
University of Wisconsin Carbone Cancer Center
Madison, Wisconsin, United States
Beijing Cancer Hospital
Beijing, Haidian District, China
Rigshospitalet (Copenhagen University Hospital) - Finsencentret - Onkologisk Klinik
Copenhagen, , Denmark
Seoul National University Hospital (SNUH)
Seoul, , South Korea
Severance Hospital Yonsei University Health System
Seoul, , South Korea
Samsung Medical Center
Seoul, , South Korea
START (Fundacion Jimenez Diaz)
Madrid, Madrid, Spain
National Taiwan University Hospital
Taipei, Taiwan, Taiwan
Kaohsiung Medical University Hospital
Kaohsiung City, , Taiwan
Veterans General Hospital - Taipei
Taipei, , Taiwan
Countries
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Other Identifiers
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KN-4802
Identifier Type: -
Identifier Source: org_study_id
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