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

Urothelial Carcinoma Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05242822
• Other study ID #: KN-4802
• Status: Active, not recruiting
• Phase: Phase 1
• Start date: April 18, 2022
• Est. completion date: September 2026

Study information

• Verified date: April 2024
• Source: Kinnate Biopharma
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Active, not recruiting
• Enrollment: 54
• Est. completion date: September 2026
• Est. primary completion date: June 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Cholangiocarcinoma
• Intrahepatic Cholangiocarcinoma
• Solid Tumor, Adult
• Urothelial Carcinoma

Intervention

Drug:
• KIN-3248
KIN-3248 will be administered orally once daily in 28-day cycles

Locations

Country	Name	City	State
China	Beijing Cancer Hospital	Beijing	Haidian District
Denmark	Rigshospitalet (Copenhagen University Hospital) - Finsencentret - Onkologisk Klinik	Copenhagen
Korea, Republic of	Samsung Medical Center	Seoul
Korea, Republic of	Seoul National University Hospital (SNUH)	Seoul
Korea, Republic of	Severance Hospital Yonsei University Health System	Seoul
Spain	START (Fundacion Jimenez Diaz)	Madrid
Taiwan	Kaohsiung Medical University Hospital	Kaohsiung
Taiwan	National Taiwan University Hospital	Taipei
Taiwan	Veterans General Hospital - Taipei	Taipei
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	START Midwest	Grand Rapids	Michigan
United States	MD Anderson Cancer Center	Houston	Texas
United States	Mayo Clinic Florida	Jacksonville	Florida
United States	UC San Diego Moores Cancer Center	La Jolla	California
United States	University of Wisconsin Carbone Cancer Center	Madison	Wisconsin
United States	Sarah Cannon Research Institute	Nashville	Tennessee
United States	NYU Langone Cancer Center	New York	New York
United States	Sarah Cannon Research Institute - Lake Nona	Orlando	Florida
United States	Fox Chase Cancer Center	Philadelphia	Pennsylvania
United States	Mayo Clinic Arizona	Phoenix	Arizona
United States	Mayo Clinic Rochester	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Kinnate Biopharma

Countries where clinical trial is conducted

United States,  China,  Denmark,  Korea, Republic of,  Spain,  Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Part A (dose escalation) - incidence of dose limiting toxicities (DLTs)		Initiation of study drug through 28 days
Primary	Part A (dose escalation) - incidence of adverse events (AEs)		Initiation of study drug through 28 days after last dose (up to approximately 18 months)
Primary	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)
Primary	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)
Primary	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)
Primary	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	Part A (dose escalation) - PK - maximum plasma concentration (Cmax) of KIN-3248		Initiation of study drug through Cycle 5 (up to approximately 4 months)
Secondary	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)
Secondary	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)