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New combo therapy targets hard-to-treat GIST tumors

NCT ID NCT05957367

Disease control Sponsor: Deciphera Pharmaceuticals, LLC Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jul 24, 2026 · Updated 4 times

Summary

This study tests a new drug called DCC-3116 combined with other cancer treatments for people with advanced GIST, a type of stomach or intestinal cancer. The goal is to find safe doses and see if the combination shrinks tumors. About 94 adults whose cancer has worsened after standard treatment can join.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 94 people

The number the study aims to enrol. It can still change while the study runs.

Started

Sep 2023

Expected to finish

Mar 2029

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Male or female ≥18 years of age * Module A: Part 1 and Part 2: Module A Part 1 and Part 2 inlexisertib combination closed on January 8, 2024, with no participants enrolled. * Module B: Only for Part 1 (Safety/Dose-finding): * Pathologically confirmed diagnosis of GIST with a KIT or platelet-derived growth factor receptor alpha (PDGFRA) mutation * Must have progressed on at least one approved systemic regimen given in the locally advanced or metastatic setting or have documented intolerance to it * Must not have received prior ripretinib treatment * Module B: Only for Part 2 (Expansion) * Pathologically confirmed GIST with documented mutation in KIT exon 11 * Must have progressed on imatinib given in the locally advanced or metastatic setting or have been intolerant to imatinib and may not have received additional systemic therapy for GIST * Must have at least 1 measurable lesion according to Modified Response Evaluation Criteria in Solid Tumors (mRECIST) * Must have a life expectancy of more than 3 months and an ECOG performance status of 0-1 * Adequate organ function and bone marrow reserve based on laboratory assessments performed at Screening * Must provide a fresh tumor biopsy, if able Exclusion Criteria: * Must not have received the following within the specified time periods prior to the first dose of study drug: 1. Medications, including anticancer therapies, that are known strong or moderate inhibitors or inducers of CYP3A4 or P-glycoprotein (P-gp) including certain herbal medications (eg, St. John's wort): 14 days or 5×the half-life of the medication (whichever is longer) 2. Other anticancer therapies and any investigational therapies with a known safety and PK profile: 14 days or 5×the half-life of the medication (whichever is shorter) 3. Investigational therapies with unknown safety and PK profile: 28 days. If there is enough data on the investigational therapy to assess the risk for drug-drug interactions and late toxicities of prior therapy as low, the Sponsor's Medical Monitor may approve a shorter washout of 14 days 4. Grapefruit or grapefruit juice: 14 days * Have not recovered from all clinically relevant toxicities from prior therapy * New York Heart Association Class III or IV heart disease, active ischemia, or any other uncontrolled cardiac condition, clinically significant cardiac arrhythmia requiring therapy, uncontrolled hypertension, congestive heart failure, or myocardial infarction within 6 months prior to the first dose of study drug * Symptomatic central nervous system (CNS) metastases or presence of leptomeningeal disease * Malabsorption syndrome * Radiation for indications other than bone disease must have been completed 4 weeks prior to first dose of study drug, unless it consisted of limited field palliative radiation, including whole brain radiation, which must have been completed at least 2 weeks prior to first dose of study drug * Major surgery within 4 weeks of the first dose of study drug * Active HIV, Hepatitis B or Hepatitis C infection

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Conditions

The condition(s) this trial relates to.

gastrointestinal stromal tumor

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

GIST

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    28 sites in 9 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • AOU Careggi - Padiglione 16 - Piano Terra - Ambulatori Oncologici - Ufficio Trial

    RECRUITING

    Florence, 50134, Italy

  • Aarhus University Hospital

    RECRUITING

    Aarhus, 8200, Denmark

  • Antonie Van Leeuwenhoek Hospital

    RECRUITING

    Amsterdam, 1066 CX, Netherlands

  • Centre Oscar Lambret

    RECRUITING

    Lille, 59020, France

  • Cleveland Clinic Taussig Cancer Center

    RECRUITING

    Cleveland, Ohio, 44195, United States

  • Fox Chase Cancer Center

    RECRUITING

    Philadelphia, Pennsylvania, 19111, United States

  • Hospital Universitario Clinico San Carlos

    RECRUITING

    Madrid, 28040, Spain

  • Hospital Universitario Ramón y Cajal

    RECRUITING

    Madrid, 28034, Spain

  • Hospital Universitario Virgen Del Rocio

    RECRUITING

    Seville, 41013, Spain

  • Hôpital Européen Georges Pompidou

    RECRUITING

    Paris, 75015, France

  • ICO Hospitalet

    RECRUITING

    Barcelona, 08908, Spain

  • IRCCS Azienda Ospedaliera Metropolitana

    RECRUITING

    Genova, 16132, Italy

  • Inselspital Universitätsklinikum Bern

    RECRUITING

    Bern, 3010, Switzerland

  • Institut Curie, Service d'Oncologie Médicale

    RECRUITING

    Paris, 75005, France

  • Instituto Português de Oncologia do Porto Francisco Gentil, E.P.E.

    RECRUITING

    Porto, 4200-072, Portugal

  • Istituto Europeo di Oncologia

    RECRUITING

    Milan, 20141, Italy

  • Memorial Sloan Kettering Cancer Center - Main Campus

    RECRUITING

    New York, New York, 10065, United States

  • Oregon Health & Science University

    RECRUITING

    Portland, Oregon, 97239, United States

  • Radboudumc

    RECRUITING

    Nijmegen, 6525GA, Netherlands

  • START Midwest

    RECRUITING

    Grand Rapids, Michigan, 49546, United States

  • Sylvester Comprehensive Cancer Center

    RECRUITING

    Miami, Florida, 33136, United States

  • UCLA Department of Medicine-Hematology/Oncology

    RECRUITING

    Los Angeles, California, 90095, United States

  • Universitatsklinikum Franfurt

    RECRUITING

    Frankfurt, 60590, Germany

  • University of Massachusetts Worcester

    RECRUITING

    Worcester, Massachusetts, 01655, United States

  • University of Southern California - Norris Comprehensive Cancer Center

    RECRUITING

    Los Angeles, California, 90033, United States

  • Universitätsklinikum Eppendorf

    RECRUITING

    Hamburg, 20246, Germany

  • Virginia Cancer Specialist, PC

    RECRUITING

    Fairfax, Virginia, 22031, United States

  • Washington University School of Medicine - Siteman Cancer Center

    RECRUITING

    St Louis, Missouri, 63110, United States

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