NCT06630234 · Deciphera Pharmaceuticals, LLC
A Master Protocol to Evaluate DCC-3009 in Gastrointestinal Stromal Tumor (GIST)
What this study is about
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.
View original scientific description
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).
Interventions
DRUG
DCC-3009
Administered orally
Primary outcome measures
Number of Participants with Dose-Limiting Toxicities (DLT) (Part 1 Escalation)
Time frame: Cycle 1 (28 Days)
DLTs assessed for each dose level.
Objective Response Rate (ORR) (Part 2 Expansion)
Time frame: Baseline to Progressive Disease (PD), Death due to Any Cause, or Start of New Antitumor Therapy (Estimated up to 24 months)
ORR is the percentage of participants with confirmed complete response (CR) or confirmed partial response (PR) based on Modified Response Evaluation Criteria in Solid Tumors (mRECIST), v1.1.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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)
Where
- Scottsdate, Arizona
- La Jolla, California
- Aurora, Colorado
- Jacksonville, Florida
- Miami, Florida
- Boston, Massachusetts
- Grand Rapids, Michigan
- Rochester, Minnesota
- New York, New York
- Nashville, Tennessee
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Feb 5, 2026 · Source of record for eligibility and locations