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Not yet recruitingRare disease

Study of DCC-3116 and ripretinib combination therapy in patients with advanced gastrointestinal stromal tumor (GIST)

Verified siteRegistered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study focuses on patients with advanced gastrointestinal stromal tumor (GIST), which is a rare type of cancer that occurs in the digestive tract. The study will test a combination of two medications: DCC-3116 and ripretinib (also known as QINLOCK). Both medications are taken by mouth in tablet form.

The purpose of this research is to evaluate how well patients with advanced GIST respond to the combination treatment of these medications. The study will look at patients whose cancer has either gotten worse after treatment with another medication called imatinib, or who could not tolerate imatinib treatment.

During the study, participants will receive both medications and will be monitored for how their cancer responds to the treatment. The doctors will track any changes in the tumor size and watch for any side effects that may occur. The study will also measure how the medications work in the body and how long the treatment effects last. Regular medical check-ups and scans will be performed to evaluate the treatment's effectiveness.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial assessment

    You will undergo initial medical evaluation to confirm eligibility for the trial

    Your doctor will verify that you have gastrointestinal stromal tumor (GIST) with a specific genetic change in KIT exon 11

    A fresh tumor sample will be collected through biopsy

    Your overall health status and organ function will be checked through laboratory tests

  2. Step 2

    Treatment initiation

    You will receive two medications taken by mouth: QINLOCK (ripretinib) 50 mg tablets and DCC-3116 in gastro-resistant tablet form

    Your doctor will provide specific instructions about when and how to take each medication

    Regular monitoring will begin to track your response to treatment

  3. Step 3

    Ongoing monitoring

    Your tumor response will be measured regularly using medical imaging

    Blood samples will be collected to monitor drug levels in your body

    Side effects will be tracked throughout the treatment period

    Your overall health status will be regularly assessed

  4. Step 4

    Treatment duration

    Treatment will continue as long as you experience benefit and tolerate the medications

    The study is planned to run until March 2029

    Your doctor will regularly evaluate if continuing treatment is appropriate for you

  5. Step 5

    Follow-up assessments

    Regular check-ups will monitor your health status

    Imaging scans will track tumor response

    Additional safety assessments will be performed as needed

Who can join the trial?

8 criteria

  • Age 18 or older
  • Must have confirmed GIST (gastrointestinal stromal tumor) with a specific genetic change in the KIT exon 11 gene
  • Disease must have gotten worse while taking imatinib (a cancer medication) or patient could not tolerate imatinib treatment. Patient should not have received any other treatments for GIST
  • Must have tumors that can be measured by medical imaging
  • Life expectancy should be more than 3 months
  • Must have good physical function, scoring either 0 or 1 on the ECOG scale (a measure of daily living abilities where 0 means fully active and 1 means restricted in strenuous activity but able to do light work)
  • Must have normal organ function and blood cell counts as shown by laboratory tests
  • Must be willing to provide a new tumor tissue sample (biopsy)

Who cannot join the trial?

14 criteria

  • Age below 18 years old
  • Pregnant or breastfeeding women
  • Previous treatment with more than 3 lines of therapy for advanced GIST (gastrointestinal stromal tumor)
  • Active or untreated brain metastases (cancer that has spread to the brain)
  • Significant heart problems, including:
    • Uncontrolled high blood pressure
    • Heart attack within the last 6 months
    • Unstable heart rhythm disorders
    • Severe liver disease
    • Severe kidney disease requiring dialysis (blood filtering treatment)
    • Active, uncontrolled infections
    • Other active cancers requiring treatment (except for adequately treated non-melanoma skin cancer or cervical cancer in situ)
    • Major surgery within 4 weeks before starting the study treatment
    • Unable to swallow oral medications
    • Any condition that would make participation unsafe or could interfere with the study results
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Investigated drugs

  • QINLOCK

    is an oral tablet taken by mouth. It contains the active ingredient ripretinib, which is used to treat certain types of cancer. In this trial, QINLOCK is being tested to see how well it works when given with other anticancer medicines in patients with advanced disease. The study will look at how many patients have their tumors shrink or stop growing while taking this medication.

  • DCC-3116

    is an experimental oral tablet that is designed to resist being broken down by stomach acid. It is a new drug that has not yet received an international name, so it is referred to by its code name, DCC-3116. In the trial, DCC-3116 is being examined in combination with other anticancer therapies to determine if the combination can improve tumor response in people with advanced cancers. The study will measure how many participants experience a reduction in tumor size or disease stabilization while taking this investigational medication.

What is already known about the treatment

DCC-3116 – An investigational medication being studied in combination with other anticancer therapies for the treatment of advanced gastrointestinal stromal tumors (GIST) and other advanced malignancies. This drug is administered orally and is currently undergoing Phase 1/2 clinical trials to evaluate its safety and effectiveness. DCC-3116 belongs to the class of targeted cancer therapies, though its specific molecular mechanism of action in cancer treatment is still being investigated through clinical research. The main focus of current trials is to determine the optimal dosing and assess the response rate when used in combination with other cancer treatments. Note: Since this is an investigational drug in early clinical trials, limited public information is available about its complete mechanism of action and pharmacological properties.

Investigated diseases

Gastrointestinal Stromal Tumor (GIST) – A rare type of cancer that begins in specialized nerve cells found in the walls of the digestive system. These tumors most commonly occur in the stomach but can be found anywhere along the digestive tract. GISTs develop from cells called interstitial cells of Cajal, which are part of the autonomic nervous system of the digestive tract. The condition typically develops slowly and may grow quite large before causing noticeable symptoms. Advanced GIST refers to tumors that have grown large or spread beyond their original location. The disease can affect both men and women at any age, though it's more common in people over 50.
Trial detailsLast updated 30 Oct 2026
Age18+ yearsPhasePhase ITrial ID2024-516476-15-00Protocol codeDCC-3116-01-002Estimated enrolment94 patientsSponsorDeciphera Pharmaceuticals Inc.

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