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Brief Title: A Study to Evaluate KIN-3248 in Participants With Advanced Tumors Harboring FGFR2 and//or FGFR3 Gene Alterations
Official Title: 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
Study ID: NCT05242822
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.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
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, , Korea, Republic of
Severance Hospital Yonsei University Health System, Seoul, , Korea, Republic of
Samsung Medical Center, Seoul, , Korea, Republic of
START (Fundacion Jimenez Diaz), Madrid, , Spain
Kaohsiung Medical University Hospital, Kaohsiung, , Taiwan
Veterans General Hospital - Taipei, Taipei, , Taiwan
National Taiwan University Hospital, Taipei, , Taiwan