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RecruitingInterventionalPhase 2

A Phase 2, Multicenter, Study Evaluating the Efficacy, Safety, Tolerability, Pharmacokinetics of KQB198 in Combination With Imatinib in Participants With Advanced/Metastatic GI Stromal Tumor in 1st Line Setting

NCT ID: NCT07406633Sponsor: Kumquat Biosciences Inc.Last updated: 2026-05-19

Summary

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.

Arms & interventions

  • DrugKQB198

    Oral KQB198

  • DrugImatinib (Gleevec)

    Oral Imatinib

Outcome measures

Primary

  • Objective response rate (ORR)

    Evaluate efficacy of study treatment, as measured by Objective Response Rate (ORR) using Response Evaluation Criteria in Gastrointestinal Stromal Tumors (GIST). Objective response is the proportion of subjects that experience confirmed complete response (CR) or partial response (PR) based on RECIST v1.1 during the time period from 1st dose of study treatment until last dose.

    Time frame: 30 months

Secondary

  • Duration of response (DOR)

    Time frame: 30 months

  • Disease control rate (DCR)

    Time frame: 30 months

  • Time to response (TTR)

    Time frame: 30 months

  • Progression-free survival (PFS)

    Time frame: Up to 30 months

  • Overall survival (OS)

    Time frame: Up to 30 months

  • Number of patients who experience treatment-emergent adverse advents, serious adverse events, and dose-limiting toxicities (Part 1)

    Time frame: From enrollment to the end of treatment

  • Area under the curve (AUC)

    Time frame: Up to 30 months

  • Maximum plasma concentration (Cmax)

    Time frame: Up to 30 months

  • Time to maximum plasma concentration (Tmax)

    Time frame: Up to 30 months

Eligibility criteria

Sex: AllAge: 18 Years and olderHealthy 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 locations (8)

USC Norris Comprehensive Cancer Center

Los Angeles, California, 90033

Recruiting

Mayo Clinic - Jacksonville

Jacksonville, Florida, 32224

Recruiting

Moffitt Cancer Center

Tampa, Florida, 33612

Recruiting

University of Michigan Hospitals

Ann Arbor, Michigan, 48109

Recruiting

Mayo Clinic - Rochester

Rochester, Minnesota, 55905

Recruiting

Cleveland Clinic

Cleveland, Ohio, 44195

Recruiting

UT MD Anderson Cancer Center

Houston, Texas, 77030

Recruiting

Fred Hutchinson Cancer Center

Seattle, Washington, 98195

Recruiting