Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at La Jolla, California and other locations
Dates
study started
estimated completion
Principal Investigator
by Shumei Kato, MD
Headshot of Shumei Kato
Shumei Kato

Description

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.

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

Details

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.

Keywords

Solid Tumor, Adult Intrahepatic Cholangiocarcinoma Urothelial Carcinoma FGFR inhibitor targeted therapy FGFR2 alteration FGFR3 alteration secondary resistance FGFR alteration Cholangiocarcinoma KIN-3248

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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

You CAN'T join if...

  • 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

  • UC San Diego Moores Cancer Center accepting new patients
    La Jolla California 92093 United States
  • Sarah Cannon Research Institute accepting new patients
    Nashville Tennessee 37203 United States

Lead Scientist at UCSD

  • Shumei Kato, MD
    Associate Clinical Professor, Medicine, Health Sciences. Authored (or co-authored) 94 research publications

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Kinnate Biopharma
ID
NCT05242822
Phase
Phase 1 research study
Study Type
Interventional
Participants
Expecting 120 study participants
Last Updated