A Master Protocol for the Multi-Cohort, Phase 1/2 Study of DCC-3116 in Combination With Anticancer Therapies in Participants With Advanced Malignancies
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.
Arms & interventions
- DrugInlexisertib
Oral Tablet Formulation
- DrugRipretinib
Oral Tablet Formulation
Outcome measures
Primary
Incidence of Adverse Events (Escalation Phase)
Identify the observed adverse events and serious adverse events associated with inlexisertib in combination with other anticancer therapies.
Time frame: Approximately 24 months
Recommended Phase 2 Doses (RP2D) (Escalation Phase)
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.
Time frame: Approximately 18 months
Objective response rate (ORR) (Expansion Phase)
Proportion of participants who achieve CR or PR per histology-specific consensus response criteria.
Time frame: Approximately 24 months
Secondary
Duration of response (DoR)
Time frame: Approximately 24 months
Disease Control Rate (DCR)
Time frame: Approximately 24 months
Time to response
Time frame: Approximately 24 months
Progression-free survival (PFS)
Time frame: Approximately 24 months
Overall Survival (OS)
Time frame: Approximately 48 months
Maximum observed concentration (Cmax)
Time frame: Predose and up to 12 hours postdose
Time to maximum observed concentration (Tmax)
Time frame: Predose and up to 12 hours postdose
Minimum observed concentration (Cmin)
Time frame: Predose and up to 12 hours postdose
Area under the concentration-time curve (AUC)
Time frame: Predose and up to 12 hours postdose
Eligibility criteria
Study locations (11)
University of Southern California - Norris Comprehensive Cancer Center
Los Angeles, California, 90033
UCLA Department of Medicine-Hematology/Oncology
Los Angeles, California, 90095
Sylvester Comprehensive Cancer Center
Miami, Florida, 33136
University of Massachusetts Worcester
Worcester, Massachusetts, 01655
START Midwest
Grand Rapids, Michigan, 49546
Washington University School of Medicine - Siteman Cancer Center
St Louis, Missouri, 63110
Memorial Sloan Kettering Cancer Center - Main Campus
New York, New York, 10065
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, 44195
Oregon Health & Science University
Portland, Oregon, 97239
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111
Virginia Cancer Specialist, PC
Fairfax, Virginia, 22031