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

Primary Purpose

Solid Tumor, Adult, Intrahepatic Cholangiocarcinoma, Urothelial Carcinoma

Status
Recruiting
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
KIN-3248
Sponsored by
Kinnate Biopharma
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Solid Tumor, Adult focused on measuring FGFR inhibitor, targeted therapy, FGFR2 alteration, FGFR3 alteration, secondary resistance, FGFR alteration

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Mayo Clinic ArizonaRecruiting
  • University of Arizona Cancer CenterRecruiting
  • UC San Diego Moores Cancer CenterRecruiting
  • Mayo Clinic FloridaRecruiting
  • Sarah Cannon Research Institute - Lake NonaRecruiting
  • Johns Hopkins Sidney Kimmel Comprehensive Cancer CenterRecruiting
  • Massachusetts General HospitalRecruiting
  • START MidwestRecruiting
  • Mayo Clinic RochesterRecruiting
  • Hackensack University Medical CenterRecruiting
  • NYU Langone Cancer CenterRecruiting
  • Memorial Sloan Kettering Cancer CenterRecruiting
  • University Hospital Cleveland Medical CenterRecruiting
  • Oregon Health and Science University (OHSU)Recruiting
  • Fox Chase Cancer CenterRecruiting
  • UPMC Hillman Cancer CenterRecruiting
  • Sarah Cannon Research InstituteRecruiting
  • MD Anderson Cancer CenterRecruiting
  • University of Wisconsin Carbone Cancer CenterRecruiting
  • Beijing Cancer HospitalRecruiting
  • Affiliated Cancer Hospital of Harbin Medical UniversityRecruiting
  • Anhui Provincial HospitalRecruiting
  • Rigshospitalet (Copenhagen University Hospital) - Finsencentret - Onkologisk KlinikRecruiting
  • Fondazione Policlinico Universitario Agostino GemelliRecruiting
  • Seoul National University Hospital (SNUH)Recruiting
  • Severance Hospital Yonsei University Health SystemRecruiting
  • Samsung Medical CenterRecruiting
  • START Barcelona HM nou DelfosRecruiting
  • START (Fundacion Jimenez Diaz)Recruiting
  • Hospital Virgen del RocioRecruiting
  • Kaohsiung Medical University HospitalRecruiting
  • Veterans General Hospital - TaipeiRecruiting
  • National Taiwan University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Part A - dose escalation

Part B - dose expansion

Arm Description

Dose escalation of KIN-3248 in patients with solid tumors

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

Outcomes

Primary Outcome Measures

Part A (dose escalation) - incidence of dose limiting toxicities (DLTs)
Part A (dose escalation) - incidence of adverse events (AEs)
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
Part B (dose expansion) - disease control rate (DCR): the proportion of participants who achieve stable disease, PR, or CR
Part B (dose expansion) - duration of response (DOR): the length of time between initial tumor response to documented tumor progression
Part B (dose expansion) - progression-free survival (PFS): the length of time until documented tumor progression

Secondary Outcome Measures

Part A (dose escalation) - PK - maximum plasma concentration (Cmax) of KIN-3248
Part A (dose escalation) - PK - time to reach maximum plasma concentration (Tmax) of KIN-3248
Part A (dose escalation) - PK - area under the plasma concentration-time curve (AUC) of KIN-3248

Full Information

First Posted
January 26, 2022
Last Updated
August 7, 2023
Sponsor
Kinnate Biopharma
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1. Study Identification

Unique Protocol Identification Number
NCT05242822
Brief Title
A Study to Evaluate KIN-3248 in Participants With Advanced Tumors Harboring FGFR2 and//or FGFR3 Gene Alterations
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 18, 2022 (Actual)
Primary Completion Date
June 2026 (Anticipated)
Study Completion Date
September 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kinnate Biopharma

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Solid Tumor, Adult, Intrahepatic Cholangiocarcinoma, Urothelial Carcinoma
Keywords
FGFR inhibitor, targeted therapy, FGFR2 alteration, FGFR3 alteration, secondary resistance, FGFR alteration

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Part A - dose escalation
Arm Type
Experimental
Arm Description
Dose escalation of KIN-3248 in patients with solid tumors
Arm Title
Part B - dose expansion
Arm Type
Experimental
Arm Description
Dose expansion evaluating the recommended dose and schedule of KIN-3248 identified from Part A
Intervention Type
Drug
Intervention Name(s)
KIN-3248
Intervention Description
KIN-3248 will be administered orally once daily in 28-day cycles
Primary Outcome Measure Information:
Title
Part A (dose escalation) - incidence of dose limiting toxicities (DLTs)
Time Frame
Initiation of study drug through 28 days
Title
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)
Title
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)
Title
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)
Title
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)
Title
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 Measure Information:
Title
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)
Title
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)
Title
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)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kinnate Clinical Operations
Email
clinicaltrials@kinnate.com
Facility Information:
Facility Name
Mayo Clinic Arizona
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85054
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Clinical Trials Referral Office
Phone
855-776-0015
Facility Name
University of Arizona Cancer Center
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85724
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Megan Hodges
Phone
520-694-9058
Email
mhodges@arizona.edu
Facility Name
UC San Diego Moores Cancer Center
City
La Jolla
State/Province
California
ZIP/Postal Code
92093
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Julia Appelt
Email
jappelt@health.ucsd.edu
Facility Name
Mayo Clinic Florida
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32224
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Clinical Trials Referral Office
Phone
855-776-0015
Facility Name
Sarah Cannon Research Institute - Lake Nona
City
Orlando
State/Province
Florida
ZIP/Postal Code
32827
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Email
asksarah@sarahcannon.com
Facility Name
Johns Hopkins Sidney Kimmel Comprehensive Cancer Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21231
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Danielle Wendler
Phone
410-502-5140
Email
JHCTN@jhmi.edu
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02214
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Joanna Caufield
Phone
617-724-4000
Email
jlcaufield@partners.org
Facility Name
START Midwest
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49546
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Email
yvette.cole@startmidwest.com
Facility Name
Mayo Clinic Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Clinical Trials Referral Office
Phone
855-776-0015
Facility Name
Hackensack University Medical Center
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Martin Gutierrez
Phone
551-996-5863
Email
martin.gutierrez@hmhn.org
Facility Name
NYU Langone Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
PCC Phase 1
Email
PCC-Phase1@nyulangone.org
Facility Name
Memorial Sloan Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
James Harding
Email
HardinJ1@MSKCC.org
Facility Name
University Hospital Cleveland Medical Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Megan Boland
Phone
216-844-3951
Email
Megan.Boland@uhhospitals.org
Facility Name
Oregon Health and Science University (OHSU)
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Knight Clinical Trials Information Line
Phone
503-494-1080
Facility Name
Fox Chase Cancer Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19111
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Efrat Dotan
Phone
215-728-3889
Email
efrat.dotan@fccc.edu
Facility Name
UPMC Hillman Cancer Center
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15232
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Immunotherapy and Drug Development Center (IDDC)
Email
IDDCreferrals@upmc.edu
Facility Name
Sarah Cannon Research Institute
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Email
asksarah@sarahcannon.com
Facility Name
MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jordi Rodan Ahnert
Phone
713-792-5603
Email
JRodon@mdanderson.org
Facility Name
University of Wisconsin Carbone Cancer Center
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53705
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cancer Connect
Phone
608-262-5223
First Name & Middle Initial & Last Name & Degree
Cancer Connect
Phone
1-800-622-892
Facility Name
Beijing Cancer Hospital
City
Beijing
State/Province
Haidian District
ZIP/Postal Code
100142
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jiajia Yuan
Email
jyuan@hsc.pku.edu.cn
Facility Name
Affiliated Cancer Hospital of Harbin Medical University
City
Harbin
State/Province
Heilongjiang
ZIP/Postal Code
150081
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dan Su
Phone
+86 13604800359
Email
471018565@qq.com
Facility Name
Anhui Provincial Hospital
City
Anhui
State/Province
Lyuang District, Hefei
ZIP/Postal Code
230061
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lianxin Liu
Phone
18096656677
Email
liulx@ustc.edu.cn
First Name & Middle Initial & Last Name & Degree
https://www.ahslyy.com.cn/cn/Scientific/list_367.html
Facility Name
Rigshospitalet (Copenhagen University Hospital) - Finsencentret - Onkologisk Klinik
City
Copenhagen
ZIP/Postal Code
2100
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Copenhagen University Hospital Phase 1 Unit Department of Oncology
Email
Thephase1unit.rigshospitalet@regionh.dk
Facility Name
Fondazione Policlinico Universitario Agostino Gemelli
City
Rome
ZIP/Postal Code
00168
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Daniele Gennaro
Phone
0039 06 3015 8802
Email
gennaro.daniele@policlinicogemelli.it
Facility Name
Seoul National University Hospital (SNUH)
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Do-Youn Oh
Phone
82-2-2072-0701
Email
ohdoyoun@snu.ac.kr
Facility Name
Severance Hospital Yonsei University Health System
City
Seoul
ZIP/Postal Code
03772
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sang Joon Shin
Phone
82-2-2228-8138
Email
SSJ338@yuhs.ac
Facility Name
Samsung Medical Center
City
Seoul
ZIP/Postal Code
06351
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jeeyun Lee
Email
jyunlee@skku.edu
Facility Name
START Barcelona HM nou Delfos
City
Barcelona
ZIP/Postal Code
08023
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tatiana Hernández Guerrero
Email
delfos@start-barcelona.com
Facility Name
START (Fundacion Jimenez Diaz)
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Victor Moreno
Phone
0034 91 550 48 00
Ext
2805
Email
victor.moreno@startmadrid.com
Facility Name
Hospital Virgen del Rocio
City
Sevilla
ZIP/Postal Code
41001
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alejandro Falcón González
Phone
+34 955014357
Email
afalconglez@gmail.com
Facility Name
Kaohsiung Medical University Hospital
City
Kaohsiung
ZIP/Postal Code
80756
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yu Chi Chang
Email
yuchichang303@nhri.edu.tw
Facility Name
Veterans General Hospital - Taipei
City
Taipei
ZIP/Postal Code
11217
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chiu-Mei Wang
Email
enjoy357208@gmail.com
Facility Name
National Taiwan University Hospital
City
Taipei
ZIP/Postal Code
80756
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chia-Hsuan Yang
Email
108711@ntuh.gov.tw

12. IPD Sharing Statement

Learn more about this trial

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

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