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NCT06630234 | RECRUITING | Gastrointestinal Stromal Tumor (GIST)

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

Deciphera Pharmaceuticals, LLC

Brief 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.

Condition or disease

Gastrointestinal Stromal Tumor (GIST)

Intervention/treatment

DCC-3009

Phase

PHASE1

PHASE2

Study Type : INTERVENTIONAL
Estimated Enrollment : 120 participants
Masking : NONE
Primary Purpose : TREATMENT
Official Title : A Master Protocol for the Multi-cohort, Open-label, Phase 1/2 Study of DCC-3009 in Participants With Gastrointestinal Stromal Tumor (GIST)
Actual Study Start Date : 2024-12-10
Estimated Primary Completion Date : 2028-05
Estimated Study Completion Date : 2028-05

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
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
A Master Protocol to Evaluate DCC-3009 in Gastrointestinal Stromal Tumor (GIST)

Location Details

NCT06630234

Please Choose a site

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, Arizona

HonorHealth

Scottsdale, Arizona, United States, 85258

RECRUITING

United States, California

UC San Diego Moores Cancer Center

THE JOLLA, California, United States, 92093

RECRUITING

United States, Florida

Mayo Clinic Florida

Jacksonville, Florida, United States, 32224

RECRUITING

United States, Florida

University of Miami - Sylvester Comprehensive Cancer Center

Miami, Florida, United States, 33136

RECRUITING

United States, Massachusetts

Dana Farber Cancer Institute

Boston, Massachusetts, United States, 02215

RECRUITING

United States, Road cancer

START Midwest

Grand Rapids, Road cancer, United States, 49546

RECRUITING

United States, New York

Memorial Sloan Kettering Cancer Center

New York, New York, United States, 10065