GIST - Gastrointestinal Stromal TumorPhase 2NCT07406633
KQB198 in Combination With Imatinib in Participants With Advanced/Metastatic GIST in 1st Line Setting (SynerGIST-1st Line)
A Phase 2 study testing KQB198 and Imatinib (Gleevec) in people with GIST - Gastrointestinal Stromal Tumor and GIST, run by Kumquat Biosciences Inc. at 17 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- GIST - Gastrointestinal Stromal Tumor, GIST, GIST Metastatic Cancer
- What is being tested?
- KQB198 and Imatinib (Gleevec)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 17 sitesUnited States
- Study dates
- 23 Jun 2026to Oct 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
17 sites in 1 country. Contact the study team or a site near you to ask about taking part.
17 sites in 1 country
United States17 sites, 17 recruiting
- Recruiting
University of Michigan Hospitals
Ann Arbor, Michigan, 48109
- Recruiting
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215
- Recruiting
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599
- Recruiting
University of Chicago Medical Center
Chicago, Illinois, 60637
- Recruiting
Cleveland Clinic
Cleveland, Ohio, 44195
- Recruiting
UT MD Anderson Cancer Center
Houston, Texas, 77030
- Recruiting
University of Iowa Health Care
Iowa City, Iowa, 52242
- Recruiting
Mayo Clinic - Jacksonville
Jacksonville, Florida, 32224
- Recruiting
Northwell Health/R.J. Zuckerberg Cancer Center
Lake Success, New York, 11042
- Recruiting
USC Norris Comprehensive Cancer Center
Los Angeles, California, 90033
- Recruiting
Sylvester Comprehensive Cancer Center
Miami, Florida, 33136
- Recruiting
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111
- Recruiting
Oregon Health & Science University
Portland, Oregon, 97239
- Recruiting
Mayo Clinic - Rochester
Rochester, Minnesota, 55905
- Recruiting
Huntsman Cancer Institute
Salt Lake City, Utah, 84112
- Recruiting
Fred Hutchinson Cancer Center
Seattle, Washington, 98109
- Recruiting
Moffitt Cancer Center
Tampa, Florida, 33612
About this study
Official 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
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
- Being tested
- KQB198, Imatinib (Gleevec)
- Keywords
- KQB198, imatinib, gleevec, gist, gastrointestinal stromal tumor, gastro intestinal stromal tumor, gist first line, gist 1st line, KQB198-103, SynerGIST, SynerGIST-1, SynerGIST-1st, SynerGIST-1st Line
- Medical subject headings
- Gastrointestinal Stromal Tumors, Digestive System Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KQB198Drug
Oral KQB198
Imatinib (Gleevec)Drug
Oral Imatinib
| Study group | Role | What they receive |
|---|---|---|
| KQB198 in Combination with Imatinib | Experimental | Not described Receives: Drug: KQB198; Drug: Imatinib (Gleevec) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 30 months
Secondary outcomes (9)
Duration of response (DOR)
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.
Measured: 30 months
Disease control rate (DCR)
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.
Measured: 30 months
Time to response (TTR)
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.
Measured: 30 months
Progression-free survival (PFS)
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.
Measured: Up to 30 months
Overall survival (OS)
Evaluate efficacy of study treatment characterized by OS. Overall survival is defined as the time from start of treatment to death.
Measured: Up to 30 months
Number of patients who experience treatment-emergent adverse advents, serious adverse events, and dose-limiting toxicities (Part 1)
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.
Measured: From enrollment to the end of treatment
Area under the curve (AUC)
Area under the concentration-time curve (AUC) of KQB198 in combination with imatinib.
Measured: Up to 30 months
Maximum plasma concentration (Cmax)
Maximum plasma concentration (Cmax) of KQB198 in combination with imatinib.
Measured: Up to 30 months
Time to maximum plasma concentration (Tmax)
Time to maximum plasma concentration (Tmax) of KQB198 in combination with imatinib.
Measured: Up to 30 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2026
- Study start23 Jun 2026
- Primary completionOct 2027 (estimated)
- Study completionOct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GIST - Gastrointestinal Stromal TumorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 46 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kumquat Biosciences Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07406633
- Sponsor's protocol ID
- KQB198-103
- Status last verified
- Jul 2026
- First submitted
- 23 Jan 2026
- Last updated
- 10 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07406633
- Acronym / sponsor ID
- KQB198-103
- Conditions
- GIST - Gastrointestinal Stromal Tumor, GIST, GIST Metastatic Cancer, Gastro Intestinal Stromal Tumour, Gastrointestinal Tumors
- Keywords
- KQB198, imatinib, gleevec, gist, gastrointestinal stromal tumor, gastro intestinal stromal tumor, gist first line, gist 1st line
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 46 participants (estimated)
- Lead sponsor
- Kumquat Biosciences Inc.Industry (pharma, biotech, devices)
- Study start
- 23 Jun 2026 (actual)
- Primary completion
- Oct 2027 (estimated)
- Study completion
- Oct 2028 (estimated)
- First posted
- 12 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| KQB198 in Combination with Imatinib | Experimental | Drug: KQB198, Drug: Imatinib (Gleevec) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| KQB198Oral KQB198 | Drug | KQB198 in Combination with Imatinib |
| Imatinib (Gleevec)Oral Imatinib | Drug | KQB198 in Combination with Imatinib |
Primary outcome
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.
9 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
17 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing KQB198 and Imatinib (Gleevec) in people with GIST - Gastrointestinal Stromal Tumor and GIST, run by Kumquat Biosciences Inc. at 17 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kumquat Clinical Development (858-214-2700, kumquatstudies@kumquatbio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective response rate (ORR) (time frame: 30 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2026.