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

Purpose

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.

Conditions

  • Solid Tumor, Adult
  • Intrahepatic Cholangiocarcinoma
  • Urothelial Carcinoma

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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

Study Design

Phase
Phase 1
Study Type
Interventional
Allocation
Non-Randomized
Intervention Model
Sequential Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Part A - dose escalation 		Dose escalation of KIN-3248 in patients with solid tumors
  • Drug: KIN-3248
    KIN-3248 will be administered orally once daily in 28-day cycles
Experimental
Part B - dose expansion 		Dose expansion evaluating the recommended dose and schedule of KIN-3248 identified from Part A
  • Drug: KIN-3248
    KIN-3248 will be administered orally once daily in 28-day cycles

More Details

Status
Active, not recruiting
Sponsor
Kinnate Biopharma

Study Contact

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.