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

Brief Title

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

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

Brief 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.

Detailed 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.

Study Phase

Phase 1

Study Type

Interventional

Primary Outcome

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

Secondary Outcome

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

Condition

Solid Tumor, Adult

Intervention

KIN-3248

Study Arms / Comparison Groups

 Part A - dose escalation

Description:  Dose escalation of KIN-3248 in patients with solid tumors

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status

Drug

Estimated Enrollment

Start Date

April 18, 2022

Completion Date

September 2026

Primary Completion Date

June 2026

Eligibility Criteria

        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

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

, , [email protected]

Location Countries

Taiwan

Location Countries

Taiwan

Administrative Informations

NCT ID

NCT05242822

Organization ID

KN-4802

Responsible Party

Sponsor

Study Sponsor

Kinnate Biopharma

Study Sponsor

, ,

Verification Date

February 2023