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

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What is this study about?

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.

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 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 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 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 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 Study?

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 Study?

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

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Azienda Ospedaliero Universitaria Careggi	Florence	Italy
Bellvitge University Hospital	L'hospitalet De Llobregat	Spain
Hospital Clinico San Carlos	Madrid	Spain
Comite Entreprise Paul Papin	Angers	France
Institut Curie – Site Paris	Paris	France

Other Sites

Site Name	City	Country
Istituto Europeo Di Oncologia S.r.l.	Milan	Italy
Instituto Portugues De Oncologia Do Porto Francisco Gentil E.P.E.	Porto	Portugal
IRCCS Ospedale Policlinico San Martino	Genoa	Italy
Virgen del Rocío University Hospital	Sevilla	Spain
Netherlands Cancer Institute	Amsterdam	The Netherlands
Stichting Radboud University Medical Center	Nijmegen	The Netherlands
Hopital Beaujon	Clichy	France
Genesis Mikti Idiotiki Kliniki Gynaikas A.E. Maieutiki Gynaikologiki Cheirourgiki	Thessaloniki	Greece
Udmrbycmso Mzzcoei Cjrjun Hnejlxmgdhfovydum	Hamburg	Germany
Abetmp Uktlltxkmp Hqwtwstb	Aarhus	Denmark
Gsvnmv Uzpluuuenh Fcbtgepef	Frankfurt	Germany
Choufb Oeezx Lhrpjpi	Lille	France

Trial status

Country	Status	Recruitment Start
Denmark	Recruiting	01.08.2025
France	Recruiting	01.08.2025
Germany	Recruiting	01.08.2025
Greece	Not yet recruiting	01.08.2025
Italy	Recruiting	01.08.2025
Portugal	Recruiting	01.08.2025
Spain	Recruiting	01.08.2025
The Netherlands	Recruiting	01.08.2025

Trial locations

Investigated drugs:

Based on the provided trial information, here is the medication description:

DCC-3116 is an experimental cancer medication being tested in combination with other cancer treatments. It is being studied in patients with advanced cancers. This is an investigational drug that is still in early phases of research (Phase 1/2) to determine how well it works when combined with other anti-cancer therapies.

Note: The specific anti-cancer therapies that will be combined with DCC-3116 are not specified in the provided data. The trial appears to be a master protocol study that will test multiple different combinations.

Investigated diseases:

Gastrointestinal stromal tumour

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 ID:

2024-516476-15-00

Protocol code:

DCC-3116-01-002

NCT ID:

NCT05957367

Trial Phase:

Human Pharmacology (Phase I) – Other

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

What is this study about?

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