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

NCT05242822 | Terminated Phase 1 FDA Drug

• 1 other identifier: KN-4802
• Study Type: interventional
• Target: 54
• Locations: 6 countries
• Sites: 21

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.

Conditions

Solid Tumor, Adult; Intrahepatic Cholangiocarcinoma; Urothelial Carcinoma

Keywords

FGFR inhibitor; targeted therapy; FGFR2 alteration; FGFR3 alteration; secondary resistance; FGFR alteration

Outcome Measures

Primary Outcomes (6)

• Part A (dose escalation) - incidence of dose limiting toxicities (DLTs)

  Initiation of study drug through 28 days

• Part A (dose escalation) - incidence of adverse events (AEs)

  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

  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

  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

  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

  Initiation of study drug until disease progression (up to approximately 36 months)

Secondary Outcomes (3)

• Part A (dose escalation) - PK - maximum plasma concentration (Cmax) of KIN-3248

  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

  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

  Initiation of study drug through Cycle 5 (up to approximately 4 months)

Study Arms (2)

Part A - dose escalation

EXPERIMENTAL

Dose escalation of KIN-3248 in patients with solid tumors

Drug: KIN-3248

Part B - dose expansion

EXPERIMENTAL

Dose expansion evaluating the recommended dose and schedule of KIN-3248 identified from Part A

Drug: KIN-3248

Interventions

KIN-3248 DRUG

KIN-3248 will be administered orally once daily in 28-day cycles

Part A - dose escalation; Part B - dose expansion

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 may not qualify 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

Sponsors & Collaborators

• Kinnate Biopharma: lead

Study Sites (21)

Mayo Clinic Arizona

Phoenix, Arizona, 85054, United States

Location

UC San Diego Moores Cancer Center

La Jolla, California, 92093, United States

Location

Mayo Clinic Florida

Jacksonville, Florida, 32224, United States

Location

Sarah Cannon Research Institute - Lake Nona

Orlando, Florida, 32827, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02214, United States

Location

START Midwest

Grand Rapids, Michigan, 49546, United States

Location

Mayo Clinic Rochester

Rochester, Minnesota, 55905, United States

Location

NYU Langone Cancer Center

New York, New York, 10016, United States

Location

Fox Chase Cancer Center

Philadelphia, Pennsylvania, 19111, United States

Location

Sarah Cannon Research Institute

Nashville, Tennessee, 37203, United States

Location

MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

University of Wisconsin Carbone Cancer Center

Madison, Wisconsin, 53705, United States

Location

Beijing Cancer Hospital

Beijing, Haidian District, 100142, China

Location

Rigshospitalet (Copenhagen University Hospital) - Finsencentret - Onkologisk Klinik

Copenhagen, 2100, Denmark

Location

Seoul National University Hospital (SNUH)

Seoul, 03080, South Korea

Location

Severance Hospital Yonsei University Health System

Seoul, 03772, South Korea

Location

Samsung Medical Center

Seoul, 06351, South Korea

Location

START (Fundacion Jimenez Diaz)

Madrid, Madrid, 28040, Spain

Location

National Taiwan University Hospital

Taipei, Taiwan, 80756, Taiwan

Location

Kaohsiung Medical University Hospital

Kaohsiung City, 80756, Taiwan

Location

Veterans General Hospital - Taipei

Taipei, 11217, Taiwan

Location

MeSH Terms

Conditions

Cholangiocarcinoma; Carcinoma, Transitional Cell

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 26, 2022
• First Posted: February 16, 2022
• Study Start: March 29, 2022
• Primary Completion: October 3, 2024
• Study Completion: October 3, 2024
• Last Updated: May 7, 2025

Record last verified: 2024-12

Locations

ES (1); US (12); KR (3); DK (1); TW (3); CN (1)