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New treatment option for GIST - Gastrointestinal Stromal Tumor
Official title KQB198 in Combination With Imatinib in Participants With Advanced/Metastatic GIST in 1st Line Setting (SynerGIST-1st Line)
ClinicalTrials.gov ID: NCT07406633
What this study is testing
What is KQB198?
KQB198 is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for gist - gastrointestinal stromal tumor.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- Measurable disease per RECIST v1.1.
You likely can't join if
- 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.
See the full eligibility 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
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Los Angeles, California, United States
- Jacksonville, Florida, United States
- Miami, Florida, United States
- Tampa, Florida, United States
- Chicago, Illinois, United States
- Iowa City, Iowa, United States
- Boston, Massachusetts, United States
- Ann Arbor, Michigan, United States
- Rochester, Minnesota, United States
- Lake Success, New York, United States
- Chapel Hill, North Carolina, United States
- Cleveland, Ohio, United States
- Portland, Oregon, United States
- Houston, Texas, United States
- Salt Lake City, Utah, United States
- Seattle, Washington, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Los Angeles, California, United States; Jacksonville, Florida, United States; Miami, Florida, United States; Tampa, Florida, United States; Chicago, Illinois, United States; Iowa City, Iowa, United States and 10 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.