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

November 30, 2023 updated by: Kinnate Biopharma

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

54

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Haidian District
      • Beijing, Haidian District, China, 100142
        • Beijing Cancer Hospital
  • Denmark
      • Copenhagen, Denmark, 2100
        • Rigshospitalet (Copenhagen University Hospital) - Finsencentret - Onkologisk Klinik
  • Korea, Republic of
      • Seoul, Korea, Republic of, 06351
        • Samsung Medical Center
      • Seoul, Korea, Republic of, 03080
        • Seoul National University Hospital (SNUH)
      • Seoul, Korea, Republic of, 03772
        • Severance Hospital Yonsei University Health System
  • Spain
      • Madrid, Spain, 28040
        • START (Fundacion Jimenez Diaz)
  • Taiwan
      • Kaohsiung, Taiwan, 80756
        • Kaohsiung Medical University Hospital
      • Taipei, Taiwan, 11217
        • Veterans General Hospital - Taipei
      • Taipei, Taiwan, 80756
        • National Taiwan University Hospital
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85054
        • Mayo Clinic Arizona
    • California
      • La Jolla, California, United States, 92093
        • UC San Diego Moores Cancer Center
    • Florida
      • Jacksonville, Florida, United States, 32224
        • Mayo Clinic Florida
      • Orlando, Florida, United States, 32827
        • Sarah Cannon Research Institute - Lake Nona
    • Massachusetts
      • Boston, Massachusetts, United States, 02214
        • Massachusetts General Hospital
    • Michigan
      • Grand Rapids, Michigan, United States, 49546
        • Start Midwest
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic Rochester
    • New York
      • New York, New York, United States, 10016
        • NYU Langone Cancer Center
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19111
        • Fox Chase Cancer Center
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • Sarah Cannon Research Institute
    • Texas
      • Houston, Texas, United States, 77030
        • MD Anderson Cancer Center
    • Wisconsin
      • Madison, Wisconsin, United States, 53705
        • University of Wisconsin Carbone Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Part A (dose escalation) - incidence of dose limiting toxicities (DLTs)
Time Frame: Initiation of study drug through 28 days
Initiation of study drug through 28 days
Part A (dose escalation) - incidence of adverse events (AEs)
Time Frame: Initiation of study drug through 28 days after last dose (up to approximately 18 months)
Initiation of study drug through 28 days after last dose (up to approximately 18 months)
Part B (dose expansion) - objective response rate (ORR): the proportion of participants who have achieved partial response (PR) or complete response (CR) according to RECIST v1.1
Time Frame: Initiation of study drug until disease progression (up to approximately 36 months)
Initiation of study drug until disease progression (up to approximately 36 months)
Part B (dose expansion) - disease control rate (DCR): the proportion of participants who achieve stable disease, PR, or CR
Time Frame: Initiation of study drug until disease progression (up to approximately 36 months)
Initiation of study drug until disease progression (up to approximately 36 months)
Part B (dose expansion) - duration of response (DOR): the length of time between initial tumor response to documented tumor progression
Time Frame: Initiation of study drug until disease progression (up to approximately 36 months)
Initiation of study drug until disease progression (up to approximately 36 months)
Part B (dose expansion) - progression-free survival (PFS): the length of time until documented tumor progression
Time Frame: Initiation of study drug until disease progression (up to approximately 36 months)
Initiation of study drug until disease progression (up to approximately 36 months)

Secondary Outcome Measures

Outcome Measure
Time Frame
Part A (dose escalation) - PK - maximum plasma concentration (Cmax) of KIN-3248
Time Frame: Initiation of study drug through Cycle 5 (up to approximately 4 months)
Initiation of study drug through Cycle 5 (up to approximately 4 months)
Part A (dose escalation) - PK - time to reach maximum plasma concentration (Tmax) of KIN-3248
Time Frame: Initiation of study drug through Cycle 5 (up to approximately 4 months)
Initiation of study drug through Cycle 5 (up to approximately 4 months)
Part A (dose escalation) - PK - area under the plasma concentration-time curve (AUC) of KIN-3248
Time Frame: Initiation of study drug through Cycle 5 (up to approximately 4 months)
Initiation of study drug through Cycle 5 (up to approximately 4 months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kinnate Biopharma

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 18, 2022

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

September 1, 2026

Study Registration Dates

First Submitted

January 26, 2022

First Submitted That Met QC Criteria

February 7, 2022

First Posted (Actual)

February 16, 2022

Study Record Updates

Last Update Posted (Estimated)

December 4, 2023

Last Update Submitted That Met QC Criteria

November 30, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KN-4802

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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