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

Stopped early · Phase 1

Conditions studied: Solid Tumor, Adult, Intrahepatic Cholangiocarcinoma, Urothelial Carcinoma

In brief

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.

Key facts

Study ID

NCT05242822

Run by

Kinnate Biopharma

People needed

54

Starts

2022-03-29

Expected to finish

2024-10-03

Last updated by the study team

2025-05-07

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• 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

Full record on ClinicalTrials.gov

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