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

June 24, 2022

Study Name
	A Study to Evaluate KIN-3248 (study drug) in Patients with Advanced Tumors Who Have FGFR2 and//or FGFR3 Gene Alterations
ClinicalTrials.gov Identifier (if applicable)
	NCT05242822
Clinical Trial Category (check all that apply)
	Beyond First Line Therapy Targeted Therapy
Study Center
Institution Name
	Multiple Sites (see below), Kinnate Biopharma Inc. (Sponsor)
State
	Multiple (see below)
Country
	United States
Website
	https://clinicaltrials.gov/ct2/show/NCT05242822
List additional Institutions (include address, phone number, and website)
	Please Visit https://clinicaltrials.gov/ct2/show/NCT05242822 for detailed information regarded the sites Sarah Cannon Research Institute, Recruiting Lake Nona, Orlando, Florida, 32827 asksarah@sarahcannon.com START Midwest, Recruiting Grand Rapids, Michigan, 49546 yvette.cole@startmidwest.com Sarah Cannon Research Institute, Recruiting Nashville, Tennessee, 37203 asksarah@sarahcannon.com
Study Contacts
Principal Investigator
	Multiple Sites
P.I. Phone
	(816) 614-3663
P.I. Email
	clinicaltrials@kinnate.com
List additional Principal Investigators (include phone number and email)
	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
List additional Study Coordinators (include phone number and email)
	Please Visit https://clinicaltrials.gov/ct2/show/NCT05242822 for detailed information regarded the sites
OVERVIEW – in layman’s terms (150 words max)
	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
	120 patient participants
Study Start Date
	04/01/2022
Estimated Completion Date
	09/01/2026
Purpose of the Study – in Layman’s Terms (use the “+” to add more list items)
	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 – Patients Must:
	• 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 – Patients Must NOT:
	• 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