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

Recruiting now · Phase 1/Phase 2

Conditions studied: GIST

In brief

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.

Key facts

Study ID

NCT05957367

Run by

Deciphera Pharmaceuticals, LLC

People needed

94

Starts

2023-09-28

Expected to finish

2029-03-01

Last updated by the study team

2026-07-23

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• Must not have received the following within the specified time periods prior to the first dose of study drug:
• 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)
• 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)
• 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
• 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

Where it is running

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

Full record on ClinicalTrials.gov

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