Back to Trials
NCT05957367PHASE1, PHASE2Recruiting

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

Deciphera Pharmaceuticals, LLC

Start Date

9/28/2023

Completion Date

3/1/2029

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 Criteria

Age Range: 18 years to No maximum

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

Interventions

DRUG

Inlexisertib

DRUG

Ripretinib

Interested in This Trial?

Contact the trial locations directly using the information below to learn more about enrollment.

Expressing interest lets you review the study and consent before we connect you with the research site.

Conditions

GIST

Locations

University of Southern California - Norris Comprehensive Cancer Center

Los Angeles, California 90033

United States

UCLA Department of Medicine-Hematology/Oncology

Los Angeles, California 90095

United States

Sylvester Comprehensive Cancer Center

Miami, Florida 33136

United States

University of Massachusetts Worcester

Worcester, Massachusetts 01655

United States

START Midwest

Grand Rapids, Michigan 49546

United States

Washington University School of Medicine - Siteman Cancer Center

St Louis, Missouri 63110

United States

Memorial Sloan Kettering Cancer Center - Main Campus

New York, New York 10065

United States

Cleveland Clinic Taussig Cancer Center

Cleveland, Ohio 44195

United States

Oregon Health & Science University

Portland, Oregon 97239

United States

Fox Chase Cancer Center

Philadelphia, Pennsylvania 19111

United States

Virginia Cancer Specialist, PC

Fairfax, Virginia 22031

United States

Aarhus University Hospital

Aarhus, 8200

Denmark

Centre Oscar Lambret

Lille, 59020

France

Institut Curie, Service d'Oncologie Médicale

Paris, 75005

France

Hôpital Européen Georges Pompidou

Paris, 75015

France

Universitatsklinikum Franfurt

Frankfurt, 60590

Germany

Universitätsklinikum Eppendorf

Hamburg, 20246

Germany

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

Florence, 50134

Italy

IRCCS Azienda Ospedaliera Metropolitana

Genova, 16132

Italy

Istituto Europeo di Oncologia

Milan, 20141

Italy

Antonie Van Leeuwenhoek Hospital

Amsterdam, 1066 CX

Netherlands

Radboudumc

Nijmegen, 6525GA

Netherlands

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

Porto, 4200-072

Portugal

ICO Hospitalet

Barcelona, 08908

Spain

Hospital Universitario Ramón y Cajal

Madrid, 28034

Spain

Hospital Universitario Clinico San Carlos

Madrid, 28040

Spain

Hospital Universitario Virgen Del Rocio

Seville, 41013

Spain

Inselspital Universitätsklinikum Bern

Bern, 3010

Switzerland