A Master Protocol to Evaluate DCC-3009 in Gastrointestinal Stromal Tumor (GIST)

Sponsor: Deciphera Pharmaceuticals, LLC

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT06630234

Patient View

This Phase 1/2 study assesses the safety and efficacy of DCC-3009 in GIST treatment. It includes dose escalation and expansion phases, with participants receiving oral DCC-3009 in 28-day cycles. Eligible participants have advanced GIST with KIT/PDGFRA mutations, prior TKI treatment, measurable lesions, ECOG PS 0-1, adequate organ function, and a life expectancy over 3 months.

Patient Parameters

Program Overview

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.

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

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