Recruiting
Phase 1
Phase 2

DCC-3009

Sponsor:

Deciphera Pharmaceuticals, LLC

Code:

NCT06630234

Conditions

Gastrointestinal Stromal Tumor (GIST)

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

DCC-3009

Study Details

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.

Conditions

Gastrointestinal Stromal Tumor (GIST)

Study ID

NCT06630234

Start date

Dec 10, 2024

Status verified date

Nov, 2025

Completion date

May, 2028

Anticipated

Primary completion date

May, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

120 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: DCC-3009 Module A

Participants will receive DCC-3009 in 28 day cycles in Module A Part 1 dose escalation and Part 2 dose expansion.

Interventions

DCC-3009

Administered orally

Primary outcome measure

  • Number of Participants with Dose-Limiting Toxicities (DLT) (Part 1 Escalation) [ Time Frame: Cycle 1 (28 Days) ]
  • 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) ]

Central Contacts and Locations

Central contacts

Clinical Team

888-724-3274clinicaltrials@deciphera.com

Locations

HonorHealth

Recruiting

Scottsdate, Arizona, United States, 85258

Contacts

Program Management

hriprograms@honorhealth.com

UC San Diego Moores Cancer Center

Recruiting

La Jolla, California, United States, 92093

University of Colorado Anschutz Medical Campus

Recruiting

Aurora, Colorado, United States, 80045

Contacts

Steven Sares

303-724-9889steven.sares@cuanschutz.edu

Mayo Clinic Florida

Recruiting

Jacksonville, Florida, United States, 32224

Contacts

Caroline Teeter

904-953-5141teeter.caroline@mayo.edu

University of Miami - Sylvester Comprehensive Cancer Center

Recruiting

Miami, Florida, United States, 33136

Contacts

Leah Anton, ARNP

305-243-2529lxa712@med.miami.edu

Dana Farber Cancer Institute

Recruiting

Boston, Massachusetts, United States, 02215

Contacts

Research Nurse

617-632-5204

START Midwest

Recruiting

Grand Rapids, Michigan, United States, 49546

Contacts

Hope Team

hopeteam@startresearch.com

Mayo Clinic Rochester

Recruiting

Rochester, Minnesota, United States, 55905

Contacts

Jordan Meyers

507-284-2030Meyers.jordan@mayo.edu

Memorial Sloan Kettering Cancer Center

Recruiting

New York, New York, United States, 10065

Contacts

Ping Chi, MD

646-888-4166chip@mskcc.org

Vanderbilt University-Ingram Cancer Center

Recruiting

Nashville, Tennessee, United States, 37232

Contacts

Vanderbilt-Ingram Cancer Center Clinical Trials Office (CTO)

800-811-8480CTIP@VUMC.ORG

More Information

Sponsor

Deciphera Pharmaceuticals, LLC

Last update posted

Feb 5, 2026

Last verified

Nov, 2025

Keywords

  • PDGFRA mutations
  • KIT mutations

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Deciphera Pharmaceuticals, LLC on 2026-02-05.