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Brief Title: KIN-3248 in Participants With Advanced Tumors Harboring FGFR2 and//or FGFR3 Gene Alterations

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

INTRODUCTION

  • Org Study ID: KN-4802
  • Secondary ID: N/A
  • NCT ID: NCT05242822
  • Sponsor: Kinnate Biopharma

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.

  • Overall Status
    Active, not recruiting
  • Start Date
    April 18, 2022
  • Phase
    Phase 1
  • Study Type
    Interventional

PRIMARY OUTCOMES

Primary Outcome 1 - Measure:

Primary Outcome 1 - Timeframe: N/A

CONDITION

  • Solid Tumor
  • Adult
  • Intrahepatic Cholangiocarcinoma
  • Urothelial Carcinoma

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

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

OFFICIAL INFORMATION

Name: N/A

Role: N/A

Affiliation: N/A

Overall Contact

Name: N/A

Phone: N/A

Email: N/A

LOCATION

Facility Status Contact

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