Cancerify Logo
Log inSign up
Back to clinical trials
RecruitingInterventionalPhase 1/Phase 2

A Master Protocol for the Multi-cohort, Open-label, Phase 1/2 Study of DCC-3009 in Participants With Gastrointestinal Stromal Tumor (GIST)

NCT ID: NCT06630234Sponsor: Deciphera Pharmaceuticals, LLCLast updated: 2026-02-05

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.

Arms & interventions

  • DrugDCC-3009

    Administered orally

Outcome measures

Primary

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

    DLTs assessed for each dose level.

    Time frame: Cycle 1 (28 Days)

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

    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.

    Time frame: Baseline to Progressive Disease (PD), Death due to Any Cause, or Start of New Antitumor Therapy (Estimated up to 24 months)

Secondary

  • Objective Response Rate (ORR) (Part 1 Escalation)

    Time frame: Baseline to Progressive Disease (PD), Death due to Any Cause, or Start of New Antitumor Therapy (Estimated up to 24 months)

  • Duration of Response (DOR)

    Time frame: First Recorded CR or PR until PD or Death (Estimated up to 24 months)

  • Progression-Free Survival (PFS)

    Time frame: Initiation of Treatment to PD or Death (Estimated up to 24 months)

  • Overall Survival (OS)

    Time frame: Initiation of Treatment to Death from Any Cause (Estimated up to 24 months)

  • Pharmacokinetics (PK): Maximum observed plasma drug concentration (Cmax)

    Time frame: Estimated up to 24 months

Eligibility criteria

Sex: AllAge: 18 Years and olderHealthy 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

Study locations (10)

HonorHealth

Scottsdate, Arizona, 85258

Recruiting
Program Management · Contact

UC San Diego Moores Cancer Center

La Jolla, California, 92093

Recruiting

University of Colorado Anschutz Medical Campus

Aurora, Colorado, 80045

Recruiting

Mayo Clinic Florida

Jacksonville, Florida, 32224

Recruiting
Caroline Teeter · Contact

University of Miami - Sylvester Comprehensive Cancer Center

Miami, Florida, 33136

Recruiting
Leah Anton, ARNP · Contact

Dana Farber Cancer Institute

Boston, Massachusetts, 02215

Recruiting
Research Nurse · Contact

START Midwest

Grand Rapids, Michigan, 49546

Recruiting
Hope Team · Contact

Mayo Clinic Rochester

Rochester, Minnesota, 55905

Recruiting
Jordan Meyers · Contact

Memorial Sloan Kettering Cancer Center

New York, New York, 10065

Recruiting
Ping Chi, MD · Contact

Vanderbilt University-Ingram Cancer Center

Nashville, Tennessee, 37232

Recruiting
Vanderbilt-Ingram Cancer Center Clinical Trials Office (CTO) · Contact