A Phase 1, Open-Label, Multicenter Study of INCB161734 in Participants With Advanced or Metastatic Solid Tumors With KRAS G12D Mutation
Incyte Corporation
Summary
This study is conducted to determine the safety and tolerability of INCB161734 as a single agent or in combination with other anticancer therapies.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * ≥18 years old. * Locally advanced or metastatic solid tumor with KRAS G12D mutation. * For Part 1a and Part 2 Combination Groups 1, 2, and 7: Disease progression on prior standard treatment, intolerance to or ineligibility for standard treatment, declined available therapies that are known to confer clinical benefit, or no standard available treatment to improve the disease outcome. * Cohort specific requirements aas defined in the protocol. * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. Exclusion Criteria: * Prior treatment with any KRAS G12…
Interventions
- DrugINCB161734
INCB161734 will be administered at protocol defined dose.
- DrugCetuximab
Cetuximab will be administered at protocol defined dose.
- DrugRetifanlimab
Retifanlimab will be administered at protocol defined dose.
- DrugGEMNabP
GEMNabP will be administered at protocol defined dose.
- DrugmFOLFIRINOX
mFOLFIRINOX will be administered at protocol defined dose.
- DrugFOLFOX
FOLFOX will be administered at protocol defined dose.
- DrugFOLFIRI
Locations (37)
- Mayo Clinic HospitalPhoenix, Arizona
- Stanford UniversityPalo Alto, California
- UCLA Healthcare Hematology-OncologySanta Monica, California
- Sarah Cannon Research Institue At HealthoneDenver, Colorado
- Mayo Clinic FloridaJacksonville, Florida
- Florida Cancer SpecialistsSarasota, Florida