A Master Protocol for the Multi-cohort, Open-label, Phase I/II Study of DCC-3009 in Participants With Gastrointestinal Stromal Tumor (GIST)

Study Identifier:
DCC-3009-01-001
CT.gov Identifier:
NCT06630234
EudraCT Identifier:
N/A
EU Trial (CTIS) Number:
N/A
Study Contact Information:
(210) 593-5651 or [email protected]
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Study Summary

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.

Medical Condition
The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.
  • Gastric
    • Phase
    The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
    I/II
    Sex
    Female & Male
    Age
    18+ years
    Study Drug
  • Drug: Experimental: DCC-3009 Module A
    • Read More
  • Drug: Drug: DCC-3009
  • Drug: Enrolled patients across monotherapy dose escalation will receive DCC-3009 orally in 28-day cycles.
    • Study Status
    Indicates the current recruitment status or the expanded access status
    Recruiting

    Requirements information
    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
    • ASCO 2025:
    • Exclusion criteria include receiving systemic anticancer therapy (encompassing investigational agents) within 14 days or less than 5 half-lives, radiotherapy within 14 days prior to first dose of study drug, prior or concurrent malignancy requiring treatment or expected to need treatment for active cancer, known allergy or hypersensitivity to the study drug components or any of its excipients, and impaired oral absorption or malabsorption syndrome.

    Clinical Study Information for Healthcare Providers

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    Study Locations

    Location
    Investigator
    Status
    Condition(s) Treated at Site
    Location
    START Midwest
    Grand Rapids, MI, United States, 49546
    Investigator
    Sreenivasa Chandana
    Status
    Recruiting
    Condition(s) Treated at Site
    Gastric