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New treatment option for Advanced Gastrointestinal Stromal Tumors
Official title (Peak) A Phase 3 Randomized Trial of CGT9486+Sunitinib vs. Sunitinib in Subjects With Gastrointestinal Stromal Tumors
ClinicalTrials.gov ID: NCT05208047
What this study is testing
What is CGT9486?
CGT9486 is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for advanced gastrointestinal stromal tumors.
Also referred to as Bezuclastinib.
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 is a Phase 3, open-label, international, multicenter study of CGT9486 in combination with sunitinib. This is a multi-part study that will enroll approximately 482 patients.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
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
- Histologically confirmed locally advanced, metastatic, and/or unresectable GIST. Molecular pathology report must be available for Part 2; if...
- Documented disease progression on or intolerance to imatinib (Part 1a, Part 1b, Part 2, DDI Substudy)
- people must have received the following treatment:
- DDI Substudy/Part 1a: Treatment with ≥1 prior lines of therapy for GIST
- Part 1b: Treatment with ≥2 prior TKI for GISTs
You likely can't join if
- Known Platelet-Derived Growth Factor Receptor (PDGFR) driving mutations or known succinate dehydrogenase deficiency (Part 1a, Part 1b, Part 2, DDI...
- Clinically significant cardiac disease
- Major surgeries (eg, abdominal laparotomy) within 4 weeks of the first dose of study drug (Part 1a, Part 1b, Part 2, DDI Substudy)
- Gastrointestinal abnormalities including, but not limited to, significant nausea and vomiting, malabsorption, external biliary shunt, or significant...
- Any active bleeding excluding hemorrhoidal or gum bleeding
- Seropositive for HIV 1 or 2, or positive for hepatitis B surface antigen or hepatitis C virus (HCV) antibody.
See the full eligibility criteria
- Histologically confirmed locally advanced, metastatic, and/or unresectable GIST. Molecular pathology report must be available for Part 2; if molecular pathology report is unavailable or inadequate, an archival or fresh...
- Documented disease progression on or intolerance to imatinib (Part 1a, Part 1b, Part 2, DDI Substudy)
- people must have received the following treatment:
- DDI Substudy/Part 1a: Treatment with ≥1 prior lines of therapy for GIST
- Part 1b: Treatment with ≥2 prior TKI for GISTs
- Part 2: Prior treatment with imatinib only
- GIST 1L Substudy: No prior systemic therapy for GIST including adjuvant therapy. Exception: up to 10 people with ongoing imatinib therapy of ≤4 weeks
- Have at least 1 measurable lesion according to mRECIST v1.1 (Part1a, Part 1b, Part 2, GIST 1L Substudy)
- Eastern Cooperative Oncology Group (ECOG) Status
- 0 to 2 (Part 1a, Part 1b, Part 2, DDI Substudy)
- 0 to 1 (GIST 1L Substudy)
- Have clinically acceptable local laboratory screening results (clinical chemistry and hematology) within certain limits Key
- Known Platelet-Derived Growth Factor Receptor (PDGFR) driving mutations or known succinate dehydrogenase deficiency (Part 1a, Part 1b, Part 2, DDI Substudy)
- Clinically significant cardiac disease
- Major surgeries (eg, abdominal laparotomy) within 4 weeks of the first dose of study drug (Part 1a, Part 1b, Part 2, DDI Substudy)
- Gastrointestinal abnormalities including, but not limited to, significant nausea and vomiting, malabsorption, external biliary shunt, or significant bowel resection that would preclude adequate absorption
- Any active bleeding excluding hemorrhoidal or gum bleeding
- Seropositive for HIV 1 or 2, or positive for hepatitis B surface antigen or hepatitis C virus (HCV) antibody.
- Active, uncontrolled, systemic bacterial, fungal, or viral infections at Screening
- Received strong CYP3A4 inhibitors or inducers (Part 1a, Part 1b, Part 2, DDI Substudy)
- Received sunitinib within 3 weeks (Part 1a, Part 1b, DDI Substudy)
The study team makes the final eligibility decision.
Where it's taking place
- Birmingham, Alabama, United States
- Scottsdale, Arizona, United States
- Tucson, Arizona, United States
- Duarte, California, United States
- Los Angeles, California, United States
- San Diego, California, United States
- San Francisco, California, United States
- Denver, Colorado, United States
- Washington D.C., District of Columbia, United States
- Jacksonville, Florida, United States
- Miami, Florida, United States
- Orange City, Florida, United States
- Orlando, Florida, United States
- Tampa, Florida, United States
- Chicago, Illinois, United States
- Iowa City, Iowa, United States
- Kansas City, Kansas, United States
- Boston, Massachusetts, United States
- Ann Arbor, Michigan, United States
- Rochester, Minnesota, United States
+ 94 more site(s).
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 Birmingham, Alabama, United States; Scottsdale, Arizona, United States; Tucson, Arizona, United States; Duarte, California, United States; Los Angeles, California, United States; San Diego, California, United States and 108 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.