A Master Protocol for the Multi-Cohort, Phase 1/2 Study of DCC-3116 in Combination With Anticancer Therapies in Participants With Advanced Malignancies
Deciphera Pharmaceuticals, LLC
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
- Age range
- 18+ years
- Sex
- All
- 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: Onl…
Interventions
- DrugInlexisertib
Oral Tablet Formulation
- DrugRipretinib
Oral Tablet Formulation
Locations (25)
- University of Southern California - Norris Comprehensive Cancer CenterLos Angeles, California
- UCLA Department of Medicine-Hematology/OncologyLos Angeles, California
- Sylvester Comprehensive Cancer CenterMiami, Florida
- University of Massachusetts WorcesterWorcester, Massachusetts
- START MidwestGrand Rapids, Michigan
- Washington University School of Medicine - Siteman Cancer CenterSt Louis, Missouri