Actively Recruiting

Phase 1
Phase 2
Age: 18Years +
All Genders
NCT06630234

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

Led by Deciphera Pharmaceuticals, LLC · Updated on 2026-02-05

120

Participants Needed

10

Research Sites

176 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

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
Not Eligible

You will not qualify if you...

  • 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

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 10 locations

1

HonorHealth

Scottsdate, Arizona, United States, 85258

Actively Recruiting

2

UC San Diego Moores Cancer Center

La Jolla, California, United States, 92093

Actively Recruiting

3

University of Colorado Anschutz Medical Campus

Aurora, Colorado, United States, 80045

Actively Recruiting

4

Mayo Clinic Florida

Jacksonville, Florida, United States, 32224

Actively Recruiting

5

University of Miami - Sylvester Comprehensive Cancer Center

Miami, Florida, United States, 33136

Actively Recruiting

6

Dana Farber Cancer Institute

Boston, Massachusetts, United States, 02215

Actively Recruiting

7

START Midwest

Grand Rapids, Michigan, United States, 49546

Actively Recruiting

8

Mayo Clinic Rochester

Rochester, Minnesota, United States, 55905

Actively Recruiting

9

Memorial Sloan Kettering Cancer Center

New York, New York, United States, 10065

Actively Recruiting

10

Vanderbilt University-Ingram Cancer Center

Nashville, Tennessee, United States, 37232

Actively Recruiting

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Research Team

C

Clinical Team

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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