(Peak) A Phase 3 Randomized Trial of CGT9486+Sunitinib vs. Sunitinib in Subjects With Gastrointestinal Stromal Tumors

Launched by COGENT BIOSCIENCES, INC. · Jan 14, 2022

Keywords

ClinConnect Summary

The clinical trial titled "Peak" is studying a new treatment approach for patients with advanced gastrointestinal stromal tumors (GISTs), a type of cancer that affects the digestive system. Researchers are comparing a combination of two medications, CGT9486 and sunitinib, to sunitinib alone to see if the combination is more effective. The study will involve around 426 participants, some of whom will first help confirm the right dose of CGT9486, while others will directly compare the effectiveness of the two treatment options.

To be eligible for this trial, patients should have a confirmed diagnosis of advanced or metastatic GIST that has progressed despite previous treatment, particularly with imatinib. Participants should also have at least one measurable tumor that can be evaluated. Throughout the study, participants will receive regular check-ups to monitor their health and the effects of the treatment. It’s important to note that certain medical conditions or recent treatments may exclude some individuals from participating. This trial aims to provide valuable information that could lead to better treatment options for patients with GISTs.

Gender

ALL

Eligibility criteria

• Key Inclusion Criteria:
• • 1. 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 tumor tissue sample will be required to evaluate mutational status prior to randomization.
• • 2. Documented disease progression on or intolerance to imatinib
• 3. Subjects 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
• • 4. Have at least 1 measurable lesion according to mRECIST v1.1 (Part1a, Part 1b, Part 2)
• • 5. ECOG - 0 to 2
• • 6. Have clinically acceptable local laboratory screening results (clinical chemistry and hematology) within certain limits
• Key Exclusion Criteria:
• • 1. Known PDGFR driving mutations or known succinate dehydrogenase deficiency
• • 2. Clinically significant cardiac disease
• • 3. Major surgeries (eg, abdominal laparotomy) within 4 weeks of the first dose of study drug
• • 4. Gastrointestinal abnormalities including, but not limited to, significant nausea and vomiting, malabsorption, external biliary shunt, or significant bowel resection that would preclude adequate absorption
• • 5. Any active bleeding excluding hemorrhoidal or gum bleeding
• • 6. Seropositive for HIV 1 or 2, or positive for hepatitis B surface antigen or hepatitis C virus (HCV) antibody.
• • 7. Active, uncontrolled, systemic bacterial, fungal, or viral infections at Screening
• • 8. Received strong CYP3A4 inhibitors or inducers
• • 9. Received sunitinib within 3 weeks (Part 1a, Part 1b, DDI Substudy)