A Phase 1/2 Study of LY3537982 in Patients With KRAS G12C-Mutant Advanced Solid Tumors
Eli Lilly and Company
Summary
The purpose of this study is to find out whether the study drug, LY3537982, is safe and effective in cancer patients who have a specific genetic mutation (KRAS G12C). Patients must have already received or were not able to tolerate the standard of care, except for specific groups who have not had cancer treatment. The study will last up to approximately 4 years.
Description
This is an open-label, multicenter Phase 1/2 study to evaluate safety, tolerability, and preliminary efficacy of oral LY3537982 in patients with KRAS G12C-mutant solid tumors. This study will be conducted in 4 parts: Phase 1a dose escalation, Phase 1b dose expansion, Phase 1b dose optimization, and Phase 2. KRAS G12C mutations will be identified through standard of care testing.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Patients have measurable disease per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1). * Patients must have disease with evidence of KRAS G12C mutation in tumor tissue or circulating tumor deoxyribonucleic acid (DNA). * Participants must have a histological or a cytologically proven diagnosis of locally advanced, unresectable, and/or metastatic cancer and meet cohort-specific criteria. * Have an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1. * Have adequate organ function. * Have discontinued all previous treatments for canc…
Interventions
- DrugLY3537982
Oral
- DrugPembrolizumab
Intravenous
- DrugCetuximab
Intravenous
- DrugPemetrexed
Intravenous
- DrugCisplatin
Intravenous
- DrugCarboplatin
Intravenous
Locations (49)
- University of Alabama at BirminghamBirmingham, Alabama
- USC Norris Cancer HospitalLos Angeles, California
- Chao Family Comprehensive Cancer Ctr.Orange, California
- Yale-New Haven HospitalNew Haven, Connecticut
- AdventHealth OrlandoOrlando, Florida
- Florida Cancer SpecialistsSarasota, Florida