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

NCT06630234 | Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: DCC-3009-01-001
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 10

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)

Keywords

PDGFRA mutations; KIT mutations

Outcome Measures

Primary Outcomes (2)

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

  DLTs assessed for each dose level.

  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.

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

Secondary Outcomes (5)

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

  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)

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

• Progression-Free Survival (PFS)

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

• Overall Survival (OS)

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

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

  Estimated up to 24 months

Study Arms (1)

DCC-3009 Module A

EXPERIMENTAL

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

Drug: DCC-3009

Interventions

DCC-3009 DRUG

Administered orally

DCC-3009 Module A

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Deciphera Pharmaceuticals, LLC: lead

Study Sites (10)

HonorHealth

Scottsdate, Arizona, 85258, United States

RECRUITING

UC San Diego Moores Cancer Center

La Jolla, California, 92093, United States

RECRUITING

University of Colorado Anschutz Medical Campus

Aurora, Colorado, 80045, United States

RECRUITING

Mayo Clinic Florida

Jacksonville, Florida, 32224, United States

RECRUITING

University of Miami - Sylvester Comprehensive Cancer Center

Miami, Florida, 33136, United States

RECRUITING

Dana Farber Cancer Institute

Boston, Massachusetts, 02215, United States

RECRUITING

START Midwest

Grand Rapids, Michigan, 49546, United States

RECRUITING

Mayo Clinic Rochester

Rochester, Minnesota, 55905, United States

RECRUITING

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

RECRUITING

Vanderbilt University-Ingram Cancer Center

Nashville, Tennessee, 37232, United States

RECRUITING

MeSH Terms

Conditions

Gastrointestinal Stromal Tumors

Condition Hierarchy (Ancestors)

Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases

Study Officials

• Clinical Team

  Deciphera Pharmaceuticals, LLC

  STUDY DIRECTOR

Central Study Contacts

Clinical Team

CONTACT

888-724-3274; clinicaltrials@deciphera.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 4, 2024
• First Posted: October 8, 2024
• Study Start: December 10, 2024
• Primary Completion (Estimated): May 1, 2028
• Study Completion (Estimated): May 1, 2028
• Last Updated: February 5, 2026

Record last verified: 2025-11

Locations

US (10)