TerminatedPhase 1

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

Stopped: Due to a change in the Sponsor's corporate strategy the study was terminated early by the Sponsor prior to enrollment into the dose expansion part of the study (Part B).

United States54 participantsStarted 2022-03-29

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

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

Timeframe: Initiation of study drug through 28 days

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

Timeframe: 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

Timeframe: 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

Timeframe: 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

Timeframe: 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

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

Trial details

NCT IDNCT05242822

SponsorKinnate Biopharma

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-10-03

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