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

Phase 1TerminatedNCT05242822

Kinnate Biopharma54 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Solid Tumor, Adult Intrahepatic Cholangiocarcinoma Urothelial Carcinoma

Interventions

KIN-3248DRUG

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (21)

Mayo Clinic Arizona

Phoenix, Arizona, United States

Outcomes

Primary Outcomes

Part A (dose escalation) - incidence of dose limiting toxicities (DLTs)

Time frame: Initiation of study drug through 28 days

Part A (dose escalation) - incidence of adverse events (AEs)

Time frame: Initiation of study drug through 28 days after last dose (up to approximately 18 months)

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

Time frame: Initiation of study drug until disease progression (up to approximately 36 months)

Part B (dose expansion) - disease control rate (DCR): the proportion of participants who achieve stable disease, PR, or CR

Time frame: Initiation of study drug until disease progression (up to approximately 36 months)

Part B (dose expansion) - duration of response (DOR): the length of time between initial tumor response to documented tumor progression

Time frame: Initiation of study drug until disease progression (up to approximately 36 months)

Part B (dose expansion) - progression-free survival (PFS): the length of time until documented tumor progression

Time frame: Initiation of study drug until disease progression (up to approximately 36 months)

Secondary Outcomes

Part A (dose escalation) - PK - maximum plasma concentration (Cmax) of KIN-3248

Time frame: Initiation of study drug through Cycle 5 (up to approximately 4 months)

Part A (dose escalation) - PK - time to reach maximum plasma concentration (Tmax) of KIN-3248

Time frame: Initiation of study drug through Cycle 5 (up to approximately 4 months)

Data from ClinicalTrials.gov

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