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Clinical Trials in the Netherlands / NCT05957367
Recruiting Phase 1/2

A Study of Inlexisertib (DCC-3116) in Combination With Anticancer Therapies in Participants With Advanced Malignancies

NCT05957367 · tracked via the Priya Life Science Netherlands tracker
Phase
Phase 1/2
Started
2023-09-28
Last updated
2026-07-23

Condition(s) studied

GIST

Investigational drug(s) / intervention(s)

InlexisertibRipretinib →

Inlexisertib: Oral Tablet Formulation

Ripretinib: Oral Tablet Formulation

Study summary

This is a Phase 1/2, multicenter, open-label (unless otherwise specified in a combination-specific module) study of inlexisertib in combination with anticancer therapies. Modules within the master protocol are defined according to different combinations of inlexisertib with other anticancer agents.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (28)

FacilityCityRegionStatus
University of Southern California - Norris Comprehensive Cancer Center Los Angeles California Recruiting
UCLA Department of Medicine-Hematology/Oncology Los Angeles California Recruiting
Sylvester Comprehensive Cancer Center Miami Florida Recruiting
University of Massachusetts Worcester Worcester Massachusetts Recruiting
START Midwest Grand Rapids Michigan Recruiting
Washington University School of Medicine - Siteman Cancer Center St Louis Missouri Recruiting
Memorial Sloan Kettering Cancer Center - Main Campus New York New York Recruiting
Cleveland Clinic Taussig Cancer Center Cleveland Ohio Recruiting
Oregon Health & Science University Portland Oregon Recruiting
Fox Chase Cancer Center Philadelphia Pennsylvania Recruiting
Virginia Cancer Specialist, PC Fairfax Virginia Recruiting
Aarhus University Hospital Aarhus Denmark Recruiting
Centre Oscar Lambret Lille France Recruiting
Institut Curie, Service d'Oncologie Médicale Paris France Recruiting
Hôpital Européen Georges Pompidou Paris France Recruiting
Universitatsklinikum Franfurt Frankfurt Germany Recruiting
Universitätsklinikum Eppendorf Hamburg Germany Recruiting
AOU Careggi - Padiglione 16 - Piano Terra - Ambulatori Oncologici - Ufficio Trial Florence Italy Recruiting
IRCCS Azienda Ospedaliera Metropolitana Genova Italy Recruiting
Istituto Europeo di Oncologia Milan Italy Recruiting
Antonie Van Leeuwenhoek Hospital Amsterdam Netherlands Recruiting
Radboudumc Nijmegen Netherlands Recruiting
Instituto Português de Oncologia do Porto Francisco Gentil, E.P.E. Porto Portugal Recruiting
ICO Hospitalet Barcelona Spain Recruiting
Hospital Universitario Ramón y Cajal Madrid Spain Recruiting
Hospital Universitario Clinico San Carlos Madrid Spain Recruiting
Hospital Universitario Virgen Del Rocio Seville Spain Recruiting
Inselspital Universitätsklinikum Bern Bern Switzerland Recruiting

More Deciphera Pharmaceuticals, LLC trials in the Netherlands

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05957367 on ClinicalTrials.gov ↗ ← All trials in the Netherlands