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

November 9, 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 3 parts: Part 1 (Dose Escalation), Part 2 (Dose Expansion), and Part 3 (Food Effect [FE] and Drug-Drug Interaction [DDI]). Participants will be treated in 28-day treatment cycles with an estimated duration of up to 2 years.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
155

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Key Inclusion Criteria:

Module A:

  • 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

Module A Part 1 (Escalation) and Part 3 (FE and DDI):

-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

Module A Part 2 (Expansion):

-Any participant with histologically or cytologically confirmed advanced or metastatic GIST with documented KIT or PDGFRA mutation

Module A Part 3 (FE and DDI):

-Able to consume a high-fat meal

Key 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

Module A Part 3 (FE and DDI):

  • Allergy or hypersensitivity to rabeprazole or any of its excipients
  • Unable or unwilling to adhere to overnight fasting of 10 hours

Other protocol-specified inclusion and exclusion criteria apply.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: DCC-3009 Module A

Participants will receive DCC-3009 in 28 day cycles in Module A Part 1 dose escalation, Part 2 dose expansion, and Part 3 FE and DDI. Participants in Part 3 will also receive rabeprazole.
Drug: DCC-3009

Administered orally

Drug: Rabeprazole

Administered orally (Part 3 only)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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)
Number of Participants with Treatment-emergent Adverse Events (TEAEs) or Serious Adverse Events (SAEs) (Part 1 Escalation)
Time Frame: Cycle 1 (28 Days)
Cycle 1 (28 Days)
Number of Participants with Dose Reduction, Interruption, or Discontinuation of Study Drug Due to TEAEs (Part 1 Escalation)
Time Frame: Cycle 1 (28 Days)
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)
Pharmacokinetics (PK): Time to Maximum Observed Plasma Concentration (Tmax) (Part 3 FE and DDI)
Time Frame: Estimated up to 24 months
Estimated up to 24 months
PK: Maximum Observed Plasma Drug Concentration (Cmax) (Part 3 FE and DDI)
Time Frame: Estimated up to 24 months
Estimated up to 24 months
PK: Trough Plasma Concentration (Ctrough) (Part 3 FE and DDI)
Time Frame: Estimated up to 24 months
Estimated up to 24 months
PK: Area Under the Plasma Concentration-time Curve (AUC) (Part 3 FE and DDI)
Time Frame: Estimated up to 24 months
Estimated up to 24 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Objective Response Rate (ORR) (Part 1 Escalation and Part 3 FE and DDI)
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)
Disease Control Rate (DCR)
Time Frame: Weeks 16, 24, 32

DCR is the proportion of participants who achieve CR, PR, or stable disease at the specified time point per mRECIST, v1.1.
Weeks 16, 24, 32
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)
Time to Response (TTR)
Time Frame: Baseline to First Recorded CR or PR (Estimated up to 24 months)

TTR for participants with confirmed CR or confirmed PR based on mRECIST, v1.1, defined as the time from initiation of treatment until the first assessment demonstrating CR or PR per mRECIST, v1.1.
Baseline to First Recorded CR or PR (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)
PK: Tmax (Part 1 Escalation and Part 2 Expansion)
Time Frame: Estimated up to 24 months
Estimated up to 24 months
PK: Cmax (Part 1 Escalation and Part 2 Expansion)
Time Frame: Estimated up to 24 months
Estimated up to 24 months
PK: Ctrough (Part 1 Escalation and Part 2 Expansion)
Time Frame: Estimated up to 24 months
Estimated up to 24 months
PK: AUC (Part 1 Escalation and Part 2 Expansion)
Time Frame: Estimated up to 24 months
Estimated up to 24 months
Number of Participants with TEAEs or SAEs (Part 2 Expansion and Part 3 FE and DDI)
Time Frame: Estimated up to 24 months
Estimated up to 24 months
Number of Participants with Dose Reduction, Interruption, or Discontinuation of Study Drug Due to TEAEs (Part 2 Expansion and Part 3 FE and DDI)
Time Frame: Estimated up to 24 months
Estimated up to 24 months

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Deciphera Pharmaceuticals, LLC

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 10, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 4, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 4, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 8, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 12, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 9, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • DCC-3009-01-001
  • 2026-525379-20-00 (Ctis)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

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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