A Study of Inlexisertib (DCC-3116) in Combination With Anticancer Therapies in Participants With Advanced Malignancies
Condition(s) studied
Investigational drug(s) / intervention(s)
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
Primary outcome measure(s)
- Incidence of Adverse Events (Escalation Phase) — Approximately 24 months
Identify the observed adverse events and serious adverse events associated with inlexisertib in combination with other anticancer therapies. - Recommended Phase 2 Doses (RP2D) (Escalation Phase) — Approximately 18 months
Identify the dose-limiting toxicities for each dose level tested and determine the recommended Phase 2 doses of inlexisertib in combination with other anticancer therapies. - Objective response rate (ORR) (Expansion Phase) — Approximately 24 months
Proportion of participants who achieve CR or PR per histology-specific consensus response criteria.
Trial sites (28)
| Facility | City | Region | Status |
|---|---|---|---|
| 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 Italy
Other trials for the same condition
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 Italy