Actively Recruiting
A Master Protocol for the Multi-cohort, Open-label Phase 1/2 Study of Oral DCC-3009 in Participants With Gastrointestinal Stromal Tumor (GIST)
Led by Deciphera Pharmaceuticals, LLC · Updated on 2026-02-05
120
Participants Needed
10
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating DCC-3009, an oral drug, for its safety, tolerability, and effectiveness in treating Gastrointestinal Stromal Tumor (GIST). This Phase 1/2 master protocol study uses a modular design where each module tests DCC-3009 alone or with other anticancer therapies. The study includes dose escalation and dose expansion phases to explore different doses and effects. Participants receive DCC-3009 in 28-day treatment cycles. Module A includes a Part 1 dose escalation phase to determine safe dosing, followed by a Part 2 dose expansion phase to further study the drug's effects. The estimated treatment duration for participants is up to 2 years. During the study, participants will be closely monitored for dose-limiting toxicities and tumor response using imaging and clinical assessments. Researchers will measure outcomes such as objective response rate, duration of response, progression-free survival, overall survival, and drug concentration in the blood. Safety and treatment effects will be assessed over an estimated 24 months of follow-up.
CONDITIONS
Brief Title
A Master Protocol to Evaluate DCC-3009 in Gastrointestinal Stromal Tumor (GIST)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older
- Histologically or cytologically confirmed advanced, unresectable, or metastatic GIST with documented KIT or PDGFRA mutation
- Progressed on or intolerant to at least one approved tyrosine kinase inhibitor (TKI) regimen for advanced/metastatic setting
- At least one measurable lesion as defined by mRECIST v1.1
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
- Adequate organ function, bone marrow function, and electrolytes
- Agreement to comply with contraception requirements
- Life expectancy of more than 3 months
You will not qualify if you...
- Received systemic anticancer therapy or radiotherapy within 14 days before the first dose of study drug
- Prior or concurrent malignancy requiring treatment or expected to require treatment for active cancer
- Known active central nervous system (CNS) metastases or active primary CNS cancer
- History or presence of serious cardiovascular abnormalities
- Major surgery within 28 days before the first dose of study drug
- Systemic arterial thrombotic or embolic events within 6 months before first dose
- Venous thrombotic or embolic events within 1 month before first dose
- 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Repeated 28-day cycles until disease progression or discontinuation
Participants receive the oral drug DCC-3009 in repeated 28-day cycles as part of dose escalation and dose expansion phases.
Visits every 28 days during treatment cycles
Trial Site Locations
Total: 10 locations
1
HonorHealth
Scottsdate, Arizona, United States, 85258
Actively Recruiting
2
UC San Diego Moores Cancer Center
La Jolla, California, United States, 92093
Actively Recruiting
3
University of Colorado Anschutz Medical Campus
Aurora, Colorado, United States, 80045
Actively Recruiting
4
Mayo Clinic Florida
Jacksonville, Florida, United States, 32224
Actively Recruiting
5
University of Miami - Sylvester Comprehensive Cancer Center
Miami, Florida, United States, 33136
Actively Recruiting
6
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02215
Actively Recruiting
7
START Midwest
Grand Rapids, Michigan, United States, 49546
Actively Recruiting
8
Mayo Clinic Rochester
Rochester, Minnesota, United States, 55905
Actively Recruiting
9
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Actively Recruiting
10
Vanderbilt University-Ingram Cancer Center
Nashville, Tennessee, United States, 37232
Actively Recruiting
Research Team
C
Clinical Team
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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