Gastrointestinal Stromal Tumor (GIST)Phase 1/2NCT06630234
A Master Protocol to Evaluate DCC-3009 in Gastrointestinal Stromal Tumor (GIST)
A Phase 1/2 study testing DCC-3009 in people with Gastrointestinal Stromal Tumor (GIST), run by Deciphera Pharmaceuticals, LLC at 10 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastrointestinal Stromal Tumor (GIST)
- What is being tested?
- DCC-3009
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 10 sitesUnited States
- Study dates
- 10 Dec 2024to May 2028
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
10 sites in 1 country. Contact the study team or a site near you to ask about taking part.
10 sites in 1 country
United States10 sites, 10 recruiting
- Recruiting
University of Colorado Anschutz Medical Campus
Aurora, Colorado, 80045
Steven Sares, 303-724-9889, steven.sares@cuanschutz.edu
- Recruiting
Dana Farber Cancer Institute
Boston, Massachusetts, 02215
Research Nurse, 617-632-5204
- Recruiting
START Midwest
Grand Rapids, Michigan, 49546
Hope Team, hopeteam@startresearch.com
- Recruiting
Mayo Clinic Florida
Jacksonville, Florida, 32224
Caroline Teeter, 904-953-5141, teeter.caroline@mayo.edu
- Recruiting
UC San Diego Moores Cancer Center
La Jolla, California, 92093
- Recruiting
University of Miami - Sylvester Comprehensive Cancer Center
Miami, Florida, 33136
Leah Anton, ARNP, 305-243-2529, lxa712@med.miami.edu
- Recruiting
Vanderbilt University-Ingram Cancer Center
Nashville, Tennessee, 37232
Vanderbilt-Ingram Cancer Center Clinical Trials Office (CTO), 800-811-8480, CTIP@VUMC.ORG
- Recruiting
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
Ping Chi, MD, 646-888-4166, chip@mskcc.org
- Recruiting
Mayo Clinic Rochester
Rochester, Minnesota, 55905
Jordan Meyers, 507-284-2030, Meyers.jordan@mayo.edu
- Recruiting
HonorHealth
Scottsdate, Arizona, 85258
Program Management, hriprograms@honorhealth.com
About this study
Official title: 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.
- Conditions
- Gastrointestinal Stromal Tumor (GIST)
- Being tested
- DCC-3009
- Keywords
- PDGFRA mutations, KIT mutations
- Medical subject headings
- Gastrointestinal Stromal Tumors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DCC-3009Drug
Administered orally
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: DCC-3009 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Dose-Limiting Toxicities (DLT) (Part 1 Escalation)
DLTs assessed for each dose level.
Measured: 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.
Measured: 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)
ORR is the percentage of participants with confirmed complete response (CR) or confirmed partial response (PR) based on mRECIST, v1.1.
Measured: 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)
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.
Measured: First Recorded CR or PR until PD or Death (Estimated up to 24 months)
Progression-Free Survival (PFS)
PFS is the time from initiation of treatment until documented disease progression per mRECIST, v1.1, or death, whichever occurs first.
Measured: Initiation of Treatment to PD or Death (Estimated up to 24 months)
Overall Survival (OS)
OS is the time from initiation of treatment to the date of death from any cause.
Measured: Initiation of Treatment to Death from Any Cause (Estimated up to 24 months)
Pharmacokinetics (PK): Maximum observed plasma drug concentration (Cmax)
Cmax
Measured: Estimated up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2024
- Study start10 Dec 2024
- Primary completionMay 2028 (estimated)
- Study completionMay 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastrointestinal Stromal Tumor (GIST)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Deciphera Pharmaceuticals, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Team, Study director, Deciphera Pharmaceuticals, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06630234
- Sponsor's protocol ID
- DCC-3009-01-001
- Status last verified
- Nov 2025
- First submitted
- 4 Oct 2024
- Last updated
- 5 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Master Protocol for the Multi-cohort, Open-label, Phase 1/2 Study of DCC-3009 in Participants With Gastrointestinal Stromal Tumor (GIST)
- ClinicalTrials.gov ID
- NCT06630234
- Acronym / sponsor ID
- DCC-3009-01-001
- Conditions
- Gastrointestinal Stromal Tumor (GIST)
- Keywords
- PDGFRA mutations, KIT mutations
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Deciphera Pharmaceuticals, LLCIndustry (pharma, biotech, devices)
- Study start
- 10 Dec 2024 (actual)
- Primary completion
- May 2028 (estimated)
- Study completion
- May 2028 (estimated)
- First posted
- 8 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| DCC-3009 Module A | Experimental | Drug: DCC-3009Participants will receive DCC-3009 in 28 day cycles in Module A Part 1 dose escalation and Part 2 dose expansion. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DCC-3009Administered orally | Drug | DCC-3009 Module A |
Primary outcome
Number of Participants with Dose-Limiting Toxicities (DLT) (Part 1 Escalation)
Time frame: Cycle 1 (28 Days)
DLTs assessed for each dose level.
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.
5 secondary outcomes
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)
Duration of Response (DOR)
Time frame: 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)
Overall Survival (OS)
Time frame: 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Clinical Team study director
Deciphera Pharmaceuticals, LLC
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing DCC-3009 in people with Gastrointestinal Stromal Tumor (GIST), run by Deciphera Pharmaceuticals, LLC at 10 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Clinical Team (888-724-3274, clinicaltrials@deciphera.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with Dose-Limiting Toxicities (DLT) (Part 1 Escalation) (time frame: Cycle 1 (28 Days)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2026.