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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
  • NTC 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
    Recruiting
  • Start Date
    April 18, 2022
  • Phase
    Phase 1
  • Study Type
    Interventional

PRIMARY OUTCOMES

Primary Outcome 1 - Measure: Part A (dose escalation) - incidence of dose limiting toxicities (DLTs)

Primary Outcome 1 - Timeframe: Initiation of study drug through 28 days

Primary Outcome 2 - Measure: Part A (dose escalation) - incidence of adverse events (AEs)

Primary Outcome 2 - Timeframe: Initiation of study drug through 28 days after last dose (up to approximately 18 months)

Primary Outcome 3 - Measure: 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

Primary Outcome 3 - Timeframe: Initiation of study drug until disease progression (up to approximately 36 months)

Primary Outcome 4 - Measure: Part B (dose expansion) - disease control rate (DCR): the proportion of participants who achieve stable disease, PR, or CR

Primary Outcome 4 - Timeframe: Initiation of study drug until disease progression (up to approximately 36 months)

Primary Outcome 5 - Measure: Part B (dose expansion) - duration of response (DOR): the length of time between initial tumor response to documented tumor progression

Primary Outcome 5 - Timeframe: Initiation of study drug until disease progression (up to approximately 36 months)

Primary Outcome 6 - Measure: Part B (dose expansion) - progression-free survival (PFS): the length of time until documented tumor progression

Primary Outcome 6 - Timeframe: Initiation of study drug until disease progression (up to approximately 36 months)

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: clinicaltrials@kinnate.com

LOCATION

Facility Status Contact
Facility: Mayo Clinic Arizona
Phoenix, Arizona 85054
United States
Status: Recruiting Contact: Contact
Clinical Trials Referral Office
855-776-0015
sifarah@health.ucsd.edu
Facility: UC San Diego Moores Cancer Center
La Jolla, California 92093
United States
Status: Recruiting Contact: Contact
Sinai Farah
858-822-6100
asksarah@sarahcannon.com
Facility: Mayo Clinic Florida
Jacksonville, Florida 32224
United States
Status: Recruiting Contact: Principal Investigator
Shumei Kato, MD
855-776-0015
yvette.cole@startmidwest.com
Facility: Sarah Cannon Research Institute - Lake Nona
Orlando, Florida 32827
United States
Status: Recruiting Contact: Contact
Clinical Trials Referral Office
855-776-0015
asksarah@sarahcannon.com
Facility: START Midwest
Grand Rapids, Michigan 49546
United States
Status: Recruiting Contact: Contact
Clinical Trials Referral Office

yuchichang303@nhri.edu.tw
Facility: Mayo Clinic Rochester
Rochester, Minnesota 55905
United States
Status: Recruiting Contact: Contact
Yu Chi Chang

enjoy357208@gmail.com
Facility: Sarah Cannon Research Institute
Nashville, Tennessee 37203
United States
Status: Recruiting Contact: Contact
Chiu-Mei Wang

108711@ntuh.gov.tw
Facility: Kaohsiung Medical University Hospital
Kaohsiung, 80756
Taiwan
Status: Recruiting Contact: Contact
Chia-Hsuan Yang

Facility: Veterans General Hospital - Taipei
Taipei, 11217
Taiwan
Status: Recruiting Contact: Contact


Facility: National Taiwan University Hospital
Taipei, 80756
Taiwan
Status: Recruiting Contact: Contact