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DCC-3009 for Gastrointestinal Stromal Tumor (GIST)

This study is testing a drug called DCC-3009 for people with advanced or metastatic Gastrointestinal Stromal Tumor (GIST). Researchers want to see if DCC-3009 is safe, tolerable, and effective. You might be able to join if you have GIST that has progressed or if you couldn't tolerate at least one other approved treatment. The study will look at how many participants experience side effects and how many see their tumors shrink or stop growing. The study is currently unclear on its recruitment status and plans to enroll about 120 people.

Study design
This is a Phase 1/2 study that will test DCC-3009 alone or with other cancer treatments. It will involve about 120 participants.
What's involved
You would receive DCC-3009 orally in 28-day treatment cycles for up to 2 years.
Compensation
Not stated in the trial record.
Follow-up
Your response to treatment will be monitored from the start of the study until your disease progresses, you pass away, or you begin a new cancer treatment, for up to 24 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06630234

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

Recruiting
PHASE1Ages 18+InterventionalTreatment
Deciphera Pharmaceuticals, LLC
~120 participants
Updated 2026-02-05 on ClinicalTrials.gov
What's tested:DCC-3009

At a glance

Recruiting sites
10 of 10 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of Participants with Dose-Limiting Toxicities (DLT) (Part 1 Escalation)
Measured over Cycle 1 (28 Days)
+1 more outcome measured

Conditions

Gastrointestinal Stromal Tumor (GIST)

Explore related trials

Gastrointestinal Stromal TumorKIT GenePDGFRA Gene

Where it's being run

10 sites across 9 states
Florida2
Arizona1
California1
Colorado1
Massachusetts1
Michigan1
Minnesota1
New York1

Study leadership

  • Clinical Team · STUDY_DIRECTOR · Deciphera Pharmaceuticals, LLC

Who to contact

Clinical Team
[email protected]
888-724-3274
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Number of Participants with Dose-Limiting Toxicities (DLT) (Part 1 Escalation)Cycle 1 (28 Days)

    DLTs assessed for each dose level.

  • Objective Response Rate (ORR) (Part 2 Expansion)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.