A Study to Evaluate KIN-3248 in Participants With Advanced Tumors Harboring FGFR2 and//or FGFR3 Gene Alterations
- Conditions
- Solid Tumor, AdultIntrahepatic CholangiocarcinomaUrothelial Carcinoma
- Interventions
- Registration Number
- NCT05242822
- Lead Sponsor
- Kinnate Biopharma
- 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 harboring FGFR2 and/or FGFR3 gene alterations.
- 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 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 54
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Part A - dose escalation KIN-3248 Dose escalation of KIN-3248 in patients with solid tumors Part B - dose expansion KIN-3248 Dose expansion evaluating the recommended dose and schedule of KIN-3248 identified from Part A
- Primary Outcome Measures
Name Time Method Part A (dose escalation) - incidence of dose limiting toxicities (DLTs) Initiation of study drug through 28 days Part A (dose escalation) - incidence of adverse events (AEs) Initiation of study drug through 28 days after last dose (up to approximately 18 months) Part B (dose expansion) - disease control rate (DCR): the proportion of participants who achieve stable disease, PR, or CR Initiation of study drug until disease progression (up to approximately 36 months) Part B (dose expansion) - objective response rate (ORR): the proportion of participants who have achieved partial response (PR) or complete response (CR) according to RECIST v1.1 Initiation of study drug until disease progression (up to approximately 36 months) Part B (dose expansion) - duration of response (DOR): the length of time between initial tumor response to documented tumor progression Initiation of study drug until disease progression (up to approximately 36 months) Part B (dose expansion) - progression-free survival (PFS): the length of time until documented tumor progression Initiation of study drug until disease progression (up to approximately 36 months)
- Secondary Outcome Measures
Name Time Method Part A (dose escalation) - PK - time to reach maximum plasma concentration (Tmax) of KIN-3248 Initiation of study drug through Cycle 5 (up to approximately 4 months) Part A (dose escalation) - PK - area under the plasma concentration-time curve (AUC) of KIN-3248 Initiation of study drug through Cycle 5 (up to approximately 4 months) Part A (dose escalation) - PK - maximum plasma concentration (Cmax) of KIN-3248 Initiation of study drug through Cycle 5 (up to approximately 4 months)
Trial Locations
- Locations (21)
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States
Fox Chase Cancer Center
🇺🇸Philadelphia, Pennsylvania, United States
Samsung Medical Center
🇰🇷Seoul, Korea, Republic of
Mayo Clinic Florida
🇺🇸Jacksonville, Florida, United States
Kaohsiung Medical University Hospital
🇨🇳Kaohsiung, Taiwan
Severance Hospital Yonsei University Health System
🇰🇷Seoul, Korea, Republic of
Veterans General Hospital - Taipei
🇨🇳Taipei, Taiwan
National Taiwan University Hospital
🇨🇳Taipei, Taiwan
UC San Diego Moores Cancer Center
🇺🇸La Jolla, California, United States
START Midwest
🇺🇸Grand Rapids, Michigan, United States
NYU Langone Cancer Center
🇺🇸New York, New York, United States
MD Anderson Cancer Center
🇺🇸Houston, Texas, United States
Beijing Cancer Hospital
🇨🇳Beijing, Haidian District, China
Seoul National University Hospital (SNUH)
🇰🇷Seoul, Korea, Republic of
Rigshospitalet (Copenhagen University Hospital) - Finsencentret - Onkologisk Klinik
🇩🇰Copenhagen, Denmark
START (Fundacion Jimenez Diaz)
🇪🇸Madrid, Spain
Mayo Clinic Arizona
🇺🇸Phoenix, Arizona, United States
Sarah Cannon Research Institute - Lake Nona
🇺🇸Orlando, Florida, United States
Mayo Clinic Rochester
🇺🇸Rochester, Minnesota, United States
Sarah Cannon Research Institute
🇺🇸Nashville, Tennessee, United States
University of Wisconsin Carbone Cancer Center
🇺🇸Madison, Wisconsin, United States