A Master Protocol to Evaluate DCC-3009 in Gastrointestinal Stromal Tumor (GIST)
NCT06630234 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 120
Last updated 2026-02-05
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.
Conditions
- Gastrointestinal Stromal Tumor (GIST)
Interventions
- DRUG
-
DCC-3009
Administered orally
Sponsors & Collaborators
-
Deciphera Pharmaceuticals, LLC
lead INDUSTRY
Principal Investigators
-
Clinical Team · Deciphera Pharmaceuticals, LLC
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-12-10
- Primary Completion
- 2028-05-31
- Completion
- 2028-05-31
- FDA Drug
- Yes
Countries
- United States
Study Locations
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