KQB198 in Combination With Imatinib in Participants With Advanced/Metastatic GIST in 1st Line Setting (SynerGIST-1st Line)

Purpose

This study will test an experimental drug called KQB198 in combination with imatinib. The goal is to determine if this combination is safe and tolerable and assess how effective the combination is at treating GIST. Imatinib has been approved by the FDA for the treatment of different types of cancer including GIST.

Conditions

  • GIST - Gastrointestinal Stromal Tumor
  • GIST
  • GIST Metastatic Cancer
  • Gastro Intestinal Stromal Tumour
  • Gastrointestinal Tumors

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

All Participants: - Unresectable or metastatic disease - Tissue confirmation of GIST - Valid results from local testing of blood or tumor tissue documenting the presence of a KIT mutation (must not have exon 9 mutation) or PDGFRA mutation (must not have PDGFRA D842V). - Measurable disease per RECIST v1.1. - Patients must be in 1st line of treatment for advanced or metastatic disease. Prior imatinib is allowed in adjuvant or neoadjuvant setting, as long as imatinib was stopped over 1 year ago. - Adequate organ function and performance status

Exclusion Criteria

Participants are excluded from the study if any of the following criteria apply: - Unable to swallow or GI condition that prevents absorption. - Other active malignancies within the last 2 years. - History of hypersensitivity to any component of KQB198 or imatinib.

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
N/A
Intervention Model
Sequential Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
KQB198 in Combination with Imatinib
  • Drug: KQB198
    Oral KQB198
  • Drug: Imatinib (Gleevec)
    Oral Imatinib

Recruiting Locations

USC Norris Comprehensive Cancer Center
Los Angeles, California 90033

Mayo Clinic - Jacksonville
Jacksonville, Florida 32224

Sylvester Comprehensive Cancer Center
Miami, Florida 33136

Moffitt Cancer Center
Tampa, Florida 33612

University of Chicago Medical Center
Chicago, Illinois 60637

University of Iowa Health Care
Iowa City, Iowa 52242

Dana-Farber Cancer Institute
Boston, Massachusetts 02215

University of Michigan Hospitals
Ann Arbor, Michigan 48109

Mayo Clinic - Rochester
Rochester, Minnesota 55905

Northwell Health/R.J. Zuckerberg Cancer Center
Lake Success, New York 11042

University of North Carolina at Chapel Hill
Chapel Hill, North Carolina 27599

Cleveland Clinic
Cleveland, Ohio 44195

Oregon Health & Science University
Portland, Oregon 97239

UT MD Anderson Cancer Center
Houston, Texas 77030

Huntsman Cancer Institute
Salt Lake City, Utah 84112

Fred Hutchinson Cancer Center
Seattle, Washington 98109

More Details

Status
Recruiting
Sponsor
Kumquat Biosciences Inc.

Study Contact

Kumquat Clinical Development
858-214-2700
kumquatstudies@kumquatbio.com