A Phase 1, Open-Label, Multicenter Study of INCB123667 as Monotherapy and in Combination With Anticancer Therapies in Participants With Selected Advanced Solid Tumors
Incyte Corporation
Summary
This is an open-label, dose-escalation and dose-expansion study to determine the safety, tolerability, PK, pharmacodynamics, and preliminary efficacy of INCB123667 when administered as monotherapy and in combination with anticancer therapies in participants with selected advanced or metastatic solid tumors. This study will consist of 2 parts. In Part 1, INCB123667 will be administered as monotherapy and in Part 2, INCB123667 will be administered in combination with anticancer therapies of interest. Each part will comprise a dose escalation portion (Parts 1a and 2a, respectively) and a dose-expansion portion (Parts 1b and 2b, respectively).
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Adults aged 18 years or older at the time of the signing of the ICF. * Life expectancy greater than 12 weeks. * ECOG performance status score of 0 or 1. * Disease progression on prior standard treatment, intolerance to or ineligibility for standard treatment, or no available treatment to improve the disease outcome. * Availability of a baseline archival tumor specimen or willingness to undergo a pretreatment and an on-treatment tumor biopsy. For Part 1: Participants in Part 1A (dose escalation): Histologically or cytologically confirmed advanced or metastatic solid tum…
Interventions
- DrugINCB0123667
25 mg tablets
- DrugPalbociclib
Palbociclib will be administered at protocol defined dose.
- DrugBevacizumab
Bevacizumab will be administered at protocol defined dose.
- DrugOlaparib
Olaparib will be administered at protocol defined dose.
- DrugPaclitaxel
Paclitaxel will be administered at protocol defined dose.
- DrugRibociclib
Ribociclib will be administered at protocol defined dose.
- DrugFulvestrant
Locations (42)
- City of Hope Medical CenterDuarte, California
- City of Hope-Lennar Foundation Cancer CenterIrvine, California
- Valkyrie Clinical TrialsLos Angeles, California
- Rocky Mountain Cancer Centers-Sky RidgeLone Tree, Colorado
- Yale Cancer CenterNew Haven, Connecticut
- Mount Sinai Medical Center Comprehensive Cancer CenterMiami Beach, Florida