Evaluating DCC-3009 for treating gastrointestinal stromal tumors
A Master Protocol for the Multi-cohort, Open-label, Phase 1/2 Study of DCC-3009 in Participants With Gastrointestinal Stromal Tumor (GIST)
This study is testing a new treatment called DCC-3009 for people with gastrointestinal stromal tumors to see if it is safe and effective, either on its own or with other cancer therapies.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Deciphera Pharmaceuticals, LLC Industry-sponsored |
| Locations | 10 sites (Scottsdate, Arizona and 9 other locations) |
| Trial ID | NCT06630234 on ClinicalTrials.gov |
What this trial studies
This Phase 1/2 master protocol study aims to assess the safety, tolerability, and effectiveness of DCC-3009 in patients with gastrointestinal stromal tumors (GIST). The study employs a modular approach, where each module focuses on DCC-3009 alone or in combination with other anticancer therapies. Participants will undergo treatment in 28-day cycles, with the study lasting up to two years. The trial includes dose escalation and expansion phases to determine the optimal dosing regimen.
Who should consider this trial
Good fit: Ideal candidates are adults with advanced or metastatic GIST who have documented KIT or PDGFRA mutations and have progressed on or were intolerant to at least one approved TKI.
Not a fit: Patients with active central nervous system malignancies or those requiring immediate treatment for other cancers may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced GIST who have not responded to existing therapies.
How similar studies have performed: Other studies have shown promise with similar approaches targeting GIST, but the specific use of DCC-3009 is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: Module A Part 1 (Escalation): * Any participant with histologically or cytologically confirmed advanced/unresectable or metastatic GIST with documented KIT or platelet-derived growth factor receptor alpha (PDGFRA) mutation, who has progressed on or was intolerant to at least 1 approved tyrosine kinase inhibitor (TKI) regimen in the advanced/metastatic setting * Have at least 1 measurable lesion as defined by mRECIST, v1.1 * Have Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0 or 1 * Adequate organ function, bone marrow function, and electrolytes * All participants agree to comply with the contraception requirements * Have a life expectancy of more than 3 months Exclusion Criteria: * Received systemic anticancer therapy or radiotherapy within 14 days prior to first dose of study drug * Prior or concurrent malignancy that requires treatment or is expected to require treatment for active cancer * Has known active central nervous system (CNS) metastases or an active primary CNS cancer * History or presence of clinically relevant cardiovascular abnormalities * Major surgery within 28 days of the first dose of study drug * Had systemic arterial thrombotic or embolic events within 6 months prior to the first dose of study drug * Had venous thrombotic events (e.g., deep vein thrombosis) or venous thrombotic embolic events (e.g., pulmonary embolism) within 1 month prior to the first dose of study drug * Known allergy or hypersensitivity to any component of the study drug * Malabsorption syndrome or other illness that could affect oral absorption * Any other clinically significant comorbidities
Where this trial is running
Scottsdate, Arizona and 9 other locations
- HonorHealth — Scottsdate, Arizona, United States (Recruiting)
- UC San Diego Moores Cancer Center — La Jolla, California, United States (Recruiting)
- University of Colorado Anschutz Medical Campus — Aurora, Colorado, United States (Recruiting)
- Mayo Clinic Florida — Jacksonville, Florida, United States (Recruiting)
- University of Miami - Sylvester Comprehensive Cancer Center — Miami, Florida, United States (Recruiting)
- Dana Farber Cancer Institute — Boston, Massachusetts, United States (Recruiting)
- START Midwest — Grand Rapids, Michigan, United States (Recruiting)
- Mayo Clinic Rochester — Rochester, Minnesota, United States (Recruiting)
- Memorial Sloan Kettering Cancer Center — New York, New York, United States (Recruiting)
- Vanderbilt University-Ingram Cancer Center — Nashville, Tennessee, United States (Recruiting)
Study contacts
- Study coordinator: Clinical Team
- Email: clinicaltrials@deciphera.com
- Phone: 888-724-3274
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.