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

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

NCT ID: NCT06630234

Condition: Gastrointestinal Stromal Tumor (GIST)

Conditions: Official terms:
Gastrointestinal Stromal Tumors

Conditions: Keywords:
PDGFRA mutations
KIT mutations

Study type: Interventional

Study phase: Phase 1/Phase 2

Overall status: Recruiting

Study design:

Allocation: N/A

Intervention model: Single Group Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Drug
Intervention name: DCC-3009
Description: Administered orally
Arm group label: DCC-3009 Module A

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.

Criteria for 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

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: START Midwest

Address:
City: Grand Rapids
Zip: 49546
Country: United States

Status: Recruiting

Start date: November 2024

Completion date: May 2028

Lead sponsor:
Agency: Deciphera Pharmaceuticals, LLC
Agency class: Industry

Source: Deciphera Pharmaceuticals, LLC

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06630234