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

February 3, 2026 updated by: Deciphera Pharmaceuticals, LLC

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

120

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Arizona
    • California
      • La Jolla, California, United States, 92093
        • Recruiting
        • UC San Diego Moores Cancer Center
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Recruiting
        • University of Colorado Anschutz Medical Campus
        • Contact:
    • Florida
      • Jacksonville, Florida, United States, 32224
      • Miami, Florida, United States, 33136
        • Recruiting
        • University of Miami - Sylvester Comprehensive Cancer Center
        • Contact:
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Recruiting
        • Dana Farber Cancer Institute
        • Contact:
          • Research Nurse
          • Phone Number: 617-632-5204
    • Michigan
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Recruiting
        • Mayo Clinic Rochester
        • Contact:
    • New York
      • New York, New York, United States, 10065
        • Recruiting
        • Memorial Sloan Kettering Cancer Center
        • Contact:
    • Tennessee
      • Nashville, Tennessee, United States, 37232
        • Recruiting
        • Vanderbilt University-Ingram Cancer Center
        • Contact:
          • Vanderbilt-Ingram Cancer Center Clinical Trials Office (CTO)
          • Phone Number: 800-811-8480
          • Email: CTIP@VUMC.ORG

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Drug: DCC-3009
Administered orally

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants with Dose-Limiting Toxicities (DLT) (Part 1 Escalation)
Time Frame: Cycle 1 (28 Days)
DLTs assessed for each dose level.
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)
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
ORR is the percentage of participants with confirmed complete response (CR) or confirmed partial response (PR) based on mRECIST, v1.1.
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)
DOR for participants with confirmed CR or confirmed PR based on mRECIST, v1.1, defined as the time interval from the time that the measurement criteria are first met for CR or PR (whichever is first recorded) until the first date that the disease progression is objectively documented or death, whichever occurs first.
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)
PFS is the time from initiation of treatment until documented disease progression per mRECIST, v1.1, or death, whichever occurs first.
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)
OS is the time from initiation of treatment to the date of death from any cause.
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
Cmax
Estimated up to 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Deciphera Pharmaceuticals, LLC

Investigators

  • Study Director: Clinical Team, Deciphera Pharmaceuticals, LLC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 10, 2024

Primary Completion (Estimated)

May 1, 2028

Study Completion (Estimated)

May 1, 2028

Study Registration Dates

First Submitted

October 4, 2024

First Submitted That Met QC Criteria

October 4, 2024

First Posted (Actual)

October 8, 2024

Study Record Updates

Last Update Posted (Actual)

February 5, 2026

Last Update Submitted That Met QC Criteria

February 3, 2026

Last Verified

November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DCC-3009-01-001

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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