A Phase I/Ib, 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

Study Identifier:
KN-4802
CT.gov Identifier:
NCT05242822
EudraCT Identifier:
202101000000
EU Trial (CTIS) Number:
N/A
Study Contact Information:
(210) 593-5651 or [email protected]
Terminated/Withdrawn

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Study Summary

To evaluate FGFR2/3 kinase inhibitor for the Treatment of FGFR2 fusion gene-positive intrahepatic cholangiocarcinoma (ICC) and FGFR3-altered urothelial carcinoma (UC).

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.

The dose escalation portion (Part A) of the trial will determine the recommended dose and schedule of KIN-3248 for further evaluation in patients with FGFR2 and/or FGFR3 gene alterations.

The dose expansion phase (Part B) of the trial will assess the safety and efficacy of KIN-3248 at the recommended dose and schedule in FGFR inhibitor naive and pretreated patients with cancers driven by FGFR2 and/or FGFR3 gene alterations, including ICC, UC and other selected adult solid tumors.

Part A is a dose-escalation assessing single agent KIN-3248 via a BOIN design to determine the MTD/RP2D

Part B will evaluate a selected dose of KIN-3248 in 3 cohorts of pts (CCA, UC, or other AMST), each driven by specified FGFR alterations—FGFRi-naïve and -pretreated pts are eligible in both parts.

Medical Condition
The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.
  • Solid Tumor
  • Bile Duct
  • Urinary tract
    • Phase
    The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
    I
    Sex
    Female & Male
    Age
    18+ years
    Study Drug
  • Drug: Experimental: Part A - dose escalation
    • Read More
  • Drug: Drug: KIN-3248
  • Drug: Experimental: Part B - dose expansion
  • Drug: ASCO 2022:
  • Drug: Chinese common name: KIN-3248 Tablets
  • Drug: ASCO GI 2023:
  • Drug: KIN-3248, spanning 6 different dose levels: 5 mg once daily (QD) (dose level; DL 1), 10 mg QD (DL 2), 20 mg QD (DL 3), 30 mg QD (DL 4), 40 mg QD (DL 5) and 50 mg QD (DL 6).
    • Study Status
    Indicates the current recruitment status or the expanded access status
    Terminated/Withdrawn

    Requirements information
    Inclusion criteria
    • Naive and pretreated patients with cancers driven by FGFR2 and/or FGFR3 gene alterations, including ICC, UC and other selected adult solid tumors.
    • 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
    • - Prior receipt of standard treatment or medical judgment that such is not appropriate.
    • Enrollment criteria include ECOG PS 0-1, intact organ function, prior receipt of standard treatment or medical judgment that such is not appropriate. Pts may have measurable or evaluable disease.
    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
    • - Active/uncontrolled HBV/HCV
    • Key exclusion criteria include known active brain metastases and active/uncontrolled HBV/HCV.

    Clinical Study Information for Healthcare Providers

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    Study Locations

    Location
    Investigator
    Status
    Condition(s) Treated at Site
    Location
    START Barcelona
    Barcelona, Spain, 08023
    Investigator
    Tatiana Hernandez Guerrero
    Status
    Recruiting
    Condition(s) Treated at Site
    Solid Tumor
    Bile Duct
    Urinary tract
    Location
    START Midwest
    Grand Rapids, MI, United States, 49546
    Investigator
    Manish Sharma
    Status
    Recruitment Complete
    Condition(s) Treated at Site
    Solid Tumor
    Bile Duct
    Urinary tract