GIST - Gastrointestinal Stromal Tumor study: KQB198 vs Imatinib
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?
an investigational oral medicine being studied as a potential treatment for gastrointestinal stromal tumor (GIST) in combination with imatinib
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 is testing whether adding KQB198 to imatinib works well. It also checks how safe the mix is and what side effects it causes.
- Who it's for
- You may be able to join if you have advanced or spread GIST cancer.
- What's involved
- You would take imatinib and the new drug KQB198. You would have regular check-ups to see how your body reacts.
- Time commitment
- The study lasts for a set time with regular visits to the clinic.
- 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
- 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.
- Patients must be in 1st line of treatment for advanced or metastatic disease.
You likely can't join if
- 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
- 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
- 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 is enrolling
- 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
- Philadelphia, Pennsylvania, 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, but 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?
This study is enrolling now at 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 11 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.