Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05242822
Recruitment Status : Recruiting
First Posted : February 16, 2022
Last Update Posted : May 9, 2022
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Solid Tumor, Adult Intrahepatic Cholangiocarcinoma Urothelial Carcinoma Drug: KIN-3248 Phase 1

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : April 18, 2022
Estimated Primary Completion Date : June 2026
Estimated Study Completion Date : September 2026


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




Primary Outcome Measures :
  1. Part A (dose escalation) - incidence of dose limiting toxicities (DLTs) [ Time Frame: Initiation of study drug through 28 days ]
  2. 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) ]
  3. 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) ]
  4. 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) ]
  5. 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) ]
  6. 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) ]

Secondary Outcome Measures :
  1. 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) ]
  2. 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) ]
  3. 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) ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05242822


Contacts
Layout table for location contacts
Contact: Kinnate Clinical Operations clinicaltrials@kinnate.com

Locations
Layout table for location information
United States, Florida
Sarah Cannon Research Institute - Lake Nona Recruiting
Orlando, Florida, United States, 32827
Contact       asksarah@sarahcannon.com   
United States, Michigan
START Midwest Recruiting
Grand Rapids, Michigan, United States, 49546
Contact       yvette.cole@startmidwest.com   
United States, Tennessee
Sarah Cannon Research Institute Recruiting
Nashville, Tennessee, United States, 37203
Contact       asksarah@sarahcannon.com   
Sponsors and Collaborators
Kinnate Biopharma
Layout table for additonal information
Responsible Party: Kinnate Biopharma
ClinicalTrials.gov Identifier: NCT05242822    
Other Study ID Numbers: KN-4802
First Posted: February 16, 2022    Key Record Dates
Last Update Posted: May 9, 2022
Last Verified: April 2022

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Kinnate Biopharma:
FGFR inhibitor
targeted therapy
FGFR2 alteration
FGFR3 alteration
secondary resistance
FGFR alteration
Additional relevant MeSH terms:
Layout table for MeSH terms
Cholangiocarcinoma
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms