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NCT Number: NCT07406633

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

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.

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Key information

Conditions

GIST - Gastrointestinal Stromal Tumor Digestive System Diseases Digestive System Neoplasms GIST GIST Metastatic Cancer Gastro Intestinal Stromal Tumour Gastrointestinal Diseases Gastrointestinal Neoplasms Gastrointestinal Stromal Tumors Gastrointestinal Tumors Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Connective Tissue Neoplasms, Connective and Soft Tissue

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

USC Norris Comprehensive Cancer Center, Los Angeles, California, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

KQB198

Drug

Oral KQB198

Imatinib (Gleevec)

Drug

Oral Imatinib

Primary outcomes

  1. Objective response rate (ORR)

    Time frame: 30 months

    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.

Secondary outcomes

  1. Duration of response (DOR)

    Time frame: 30 months

    Duration of response defined as the time from date of the first documentation of objective tumor response (CR or PR) based on RECIST v1.1 to the first documentation of either PD or death due to any cause, whichever occurs first.

  2. Disease control rate (DCR)

    Time frame: 30 months

    Disease control rate is the proportion of subjects that experience confirmed complete response (CR), partial response (PR), or stable disease based on RECIST v1.1 during the time period from 1st dose of study treatment until last dose.

  3. Time to response (TTR)

    Time frame: 30 months

    Time to response is defined as time from 1st dose of study treatment to date of 1st documentation of objective tumor response (CR or PR) based on RECIST v1.1.

  4. Progression-free survival (PFS)

    Time frame: Up to 30 months

    Progression-free survival is defined as the time from enrollment to the date of Progressive Disease (PD) based on RECIST v1.1 or death due to any cause, whichever occurs first. PFS at 6 months will also be characterized which indicates the proportion of subjects that experience progression within 6 months from time of enrollment.

  5. Overall survival (OS)

    Time frame: Up to 30 months

    Evaluate efficacy of study treatment characterized by OS. Overall survival is defined as the time from start of treatment to death.

  6. 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

    Safety characterized by type, incidence, severity, timing, seriousness and relationship to study treatment of adverse events (AEs), serious adverse events (SAEs), and dose limiting toxicities (DLTs), from first dose of study treatment to 28 days after last dose of study treatment.

  7. Area under the curve (AUC)

    Time frame: Up to 30 months

    Area under the concentration-time curve (AUC) of KQB198 in combination with imatinib.

  8. Maximum plasma concentration (Cmax)

    Time frame: Up to 30 months

    Maximum plasma concentration (Cmax) of KQB198 in combination with imatinib.

  9. Time to maximum plasma concentration (Tmax)

    Time frame: Up to 30 months

    Time to maximum plasma concentration (Tmax) of KQB198 in combination with imatinib.

Study contacts

Contact information is provided by the study sponsor or research team.

Kumquat Clinical Development

CONTACT

[email protected]

858-214-2700

Sponsors and collaborators

Lead sponsor

Kumquat Biosciences Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Feb 12, 2026
Registry last updated
Jul 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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