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A Master Protocol to Evaluate DCC-3009 in Gastrointestinal Stromal Tumor (GIST)
Trial Status: active
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.
Inclusion 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
Additional locations may be listed on ClinicalTrials.gov for NCT06630234.
