Ireland
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Recruiting Phase 1/2

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

NCT06630234 · tracked via the Priya Life Science USA tracker
Phase
Phase 1/2
Started
2024-12-10
Last updated
2026-02-05

Condition(s) studied

Gastrointestinal Stromal Tumor (GIST)

Investigational drug(s) / intervention(s)

DCC-3009

DCC-3009: Administered orally

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • 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.

Trial sites (10)

FacilityCityRegionStatus
HonorHealth Scottsdate Arizona Recruiting
UC San Diego Moores Cancer Center La Jolla California Recruiting
University of Colorado Anschutz Medical Campus Aurora Colorado Recruiting
Mayo Clinic Florida Jacksonville Florida Recruiting
University of Miami - Sylvester Comprehensive Cancer Center Miami Florida Recruiting
Dana Farber Cancer Institute Boston Massachusetts Recruiting
START Midwest Grand Rapids Michigan Recruiting
Mayo Clinic Rochester Rochester Minnesota Recruiting
Memorial Sloan Kettering Cancer Center New York New York Recruiting
Vanderbilt University-Ingram Cancer Center Nashville Tennessee Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06630234 on ClinicalTrials.gov ↗ ← All trials in the USA