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A Master Protocol to Evaluate DCC-3009 in Gastrointestinal Stromal Tumor (GIST)
A Master Protocol for the Multi-cohort, Open-label, Phase 1/2 Study of DCC-3009 in Participants With Gastrointestinal Stromal Tumor (GIST)
Who can join
Ages 18 and older · All sexes
Full eligibility 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
About the study
The purpose of this Phase 1/2 master protocol study is to evaluate if DCC-3009 is safe, tolerable and works effectively in the treatment of GIST. The study will use a modular approach with each module being defined according to therapy: DCC-3009 alone or DCC-3009 in combination with other anticancer therapies. Each module will be conducted in 2 parts: Part 1 (Dose Escalation) and Part 2 (Dose Expansion). Participants will be treated in 28-day treatment cycles with an estimated duration of up to 2 years.
What is being tested
- DCC-3009 (drug)
Sponsor: Deciphera Pharmaceuticals, LLC · Participants: 120 · Started: Dec 10, 2024
Contact the study team
- Clinical Team · Phone: 888-724-3274
Official record on ClinicalTrials.gov — NCT06630234
Locations in the U.S.
| Arizona | HonorHealth, Scottsdate |
| California | UC San Diego Moores Cancer Center, La Jolla |
| Colorado | University of Colorado Anschutz Medical Campus, Aurora |
| Florida | Mayo Clinic Florida, Jacksonville University of Miami - Sylvester Comprehensive Cancer Center, Miami |
| Massachusetts | Dana Farber Cancer Institute, Boston |
| Michigan | START Midwest, Grand Rapids |
| Minnesota | Mayo Clinic Rochester, Rochester |
| New York | Memorial Sloan Kettering Cancer Center, New York |
| Tennessee | Vanderbilt University-Ingram Cancer Center, Nashville |
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.