A Study of LY3499446 in Participants With Advanced Solid Tumors With KRAS G12C Mutation
Advanced Solid Tumor, Non-Small Cell Lung Cancer, Colorectal Cancer
About this trial
This is an interventional treatment trial for Advanced Solid Tumor
Eligibility Criteria
Inclusion Criteria:
- Participants must have diagnosis of a solid tumor with KRAS G12C mutation that did not respond to at least 1 line of standard therapy and has spread to other part(s) of the body
- For phase II, participants must be willing to have new tumor tissue biopsies (doctor removes a small amount of tissue) during the study if it does not cause undue risks to health
- Participants must be willing to use highly effective birth control
- Participants must have adequate organ function
- Participants must be able to swallow capsules
Exclusion Criteria:
- Participants must not have certain infections such as hepatitis or tuberculosis or HIV that is not well controlled
- Participants must not have another serious medical condition including a serious heart condition, such as congestive heart failure, unstable angina pectoris, or heart attack within the last three months
- Participants must not have cancer of the central nervous system that is not stable
- Participants must not be pregnant or breastfeeding
- Participants must not use herbal supplements
Sites / Locations
- Indiana Univ Melvin & Bren Simon Cancer Center
- Memorial Sloan Kettering Cancer Center
- Memorial Sloan Kettering Cancer Center
- Memorial Sloan Kettering Cancer Center
- St Vincent's Hospital
- Linear Clinical Research Ltd
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Experimental
Experimental
Experimental
Experimental
Experimental
Active Comparator
LY3499446 Phase 1 Cohort A1 High Dose
LY3499446 Phase 1 Cohort AO Mid Dose
LY3499446 Phase 1 Cohort A-2 Low Dose
LY3499446 + Combination Drugs Phase 1
LY3499446 Monotherapy + Combination Drugs Phase 2
Docetaxel Phase 2
Participants received high dose LY3499446 as oral monotherapy twice daily (BID) in 21-day cycles.
Participant received mid dose LY3499446 as oral monotherapy once every other day (QOD) in 21-day cycles.
Participants received low dose LY3499446 as oral monotherapy once daily (QD) in 21-Day cycles.
LY3499446 combined with either abemaciclib (orally), erlotinib (orally), or cetuximab (IV). This trial was terminated prior to initiation of combination therapy cohorts.
LY3499446 as oral monotherapy and LY3499446 combined with either abemaciclib (orally), erlotinib (orally), or cetuximab (IV). The trial was terminated prior to initiation of Phase 2 of this study.
Docetaxel IV infusion. The trial was terminated prior to initiation of Phase 2 of this study.