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A Study to Evaluate KIN-3248 (study drug) in Patients with Advanced Tumors Who Have FGFR2 and//or FGFR3 Gene Alterations

ClinicalTrials.gov Identifier
NCT05242822
Institution Name
Multiple Sites (see below), Kinnate Biopharma Inc. (Sponsor)
Full Institution Address





United States
Institution Website
https://clinicaltrials.gov/ct2/show/NCT05242822
Additional Institutions
Principal Investigator
Multiple Sites
Principal Investigator Phone
(816) 614-3663
Principal Investigator Email
clinicaltrials@kinnate.com
Additional Principal Investigators
Please Visit https://clinicaltrials.gov/ct2/show/NCT05242822 for detailed information regarded the sites
Study Coordinator
Multiple Sites
Study Coordinator Phone
(816) 614-3663
Study Coordinator Email
clinicaltrials@kinnate.com
Additional Study Coordinators
Please Visit https://clinicaltrials.gov/ct2/show/NCT05242822 for detailed information regarded the sites
Study Overview
This is an open label study in adults with advanced tumors who have FGFR2 and/or FGFR3 mutations. Participants receive daily medicine by mouth of KIN-3248 (study drug) with periodic study visits (ranging from weekly at the beginning of the trial to monthly) to have laboratory testing, imaging assessments and safety exams such as ECG, physical exam
Enrollment Information
120 patient participants
Study Start Date
20220401
Study End Date
20260901
Study Purpose

  • The study drug, KIN-3248, belongs to a group of anti-cancer drugs called FGFR inhibitors. Cancer can form when there are changes (mutations) in the FGFR gene. FGFR mutations are found in cholangiocarcinoma, and bladder cancers specifically, but have also been detected in other cancers as well. This study is divided into two parts:

  • Part A will look at the safety of different doses of the study drug to determine which dose should be used in Part B.

  • Part B will continue to look at the safety of the chosen dose of the study drug from Part A and test whether it can slow down or stop a cancer tumor from growing.
Inclusion Criteria

  • Provide written informed consent prior to initiation of any study-specific procedures

  • Have advanced stage solid tumor with known FGFR2 and/or FGFR3 gene alteration, as confirmed by previous genomic analysis of tumor tissue or ctDNA

  • Have measurable or evaluable disease according to RECIST v1.1

  • Have an ECOG performance status 0 or 1

  • Have adequate organ function, as measured by laboratory values (criteria listed in protocol)

  • Be able to swallow, retain, and absorb medications taken by mouth
Exclusion Criteria

  • Have known clinically-active or clinically-progressive brain metastases from non-brain tumors

  • Have a history and/or current evidence of abnormal calcium-phosphorous homeostasis, ectopic mineralization or calcification, or corneal or retinal disorder/keratopathy

  • Have GI tract disease causing an inability to take oral medication, malabsorption syndrome, requirement for intravenous alimentation, or uncontrolled inflammatory GI disease

  • Have active, uncontrolled bacterial, fungal, or viral infection

  • Be women who are lactating or breastfeeding, or pregnant
Financial Assistance Available
No