The reason for this study is to see if the study drug LY3499446 is safe and effective in participants with solid tumors with KRAS G12C mutation.
Name: LY3499446
Name: Abemaciclib
Name: Cetuximab
Name: Erlotinib
Name: Docetaxel
Description: Phase 1: Number or Participants with DLTs
Measure: Phase 1: Number or Participants with Dose Limiting Toxicities (DLTs) Time: Cycle 1 (21 Day Cycle)Description: Phase 2: ORR: Percentage of Participants Who Achieve CR or PR (CRC Cohorts and Other Tumors Cohort)
Measure: Phase 2: Overall Response Rate (ORR): Percentage of Participants Who Achieve Complete Response (CR) or Partial Response (PR) (CRC Cohorts and Other Tumors Cohort) Time: Baseline through Measured Progressive Disease (Estimated up to 24 Months)Description: Phase 2: PFS (NSCLC Cohorts)
Measure: Phase 2: Progression-Free Survival (PFS) (NSCLC Cohorts) Time: Baseline to Objective Progression or Death Due to Any Cause (Estimated up to 24 Months)Description: PK: Average Concentration at Steady State of LY3499446
Measure: Pharmacokinetics (PK): Average Concentration at Steady State of LY3499446 Time: Predose Cycle 1 Day 1 through Cycle 3 Day 1 (21 Day Cycles)Description: PK: Average Concentration at Steady State of LY3499446 in Combination with Abemaciclib
Measure: PK: Average Concentration at Steady State of LY3499446 in Combination with Abemaciclib Time: Predose Cycle 1 Day 1 through Cycle 3 Day 1 (21 Day Cycles)Description: PK: Average Concentration at Steady State of LY3499446 in Combination with Cetuximab
Measure: PK: Average Concentration at Steady State of LY3499446 in Combination with Cetuximab Time: Predose Cycle 1 Day 1 through Cycle 3 Day 1 (21 Day Cycles)Description: PK: Average Concentration at Steady State of LY3499446 in Combination with Erlotinib
Measure: PK: Average Concentration at Steady State of LY3499446 in Combination with Erlotinib Time: Predose Cycle 1 Day 1 through Cycle 3 Day 1 (21 Day Cycles)Description: Phase 1: ORR: Percentage of Participants Who Achieve CR or PR
Measure: Phase 1: ORR: Percentage of Participants Who Achieve CR or PR Time: Baseline through Measured Progressive Disease (Estimated up to 24 Months)Description: Phase 1: PFS
Measure: Phase 1: PFS Time: Baseline to Objective Progression or Death Due to Any Cause (Estimated up to 24 Months)Description: DoR
Measure: Duration of Response (DoR) Time: Date of CR or PR to Date of Disease Progression or Death Due to Any Cause (Estimated up to 24 Months)Description: Disease Control Rate (DCR): Percentage of Participants with a Best Overall Response of CR, PR, and SD
Measure: Disease Control Rate (DCR): Percentage of Participants with a Best Overall Response of CR, PR, and SD Time: Baseline through Measured Progressive Disease (Estimated up to 24 Months)Allocation: Randomized
Parallel Assignment
There is one SNP
A Phase 1/2 Study of LY3499446 Administered to Patients With Advanced Solid Tumors With KRAS G12C Mutation. --- G12C ---
A Study of LY3499446 in Participants With Advanced Solid Tumors With KRAS G12C Mutation The reason for this study is to see if the study drug LY3499446 is safe and effective in participants with solid tumors with KRAS G12C mutation. --- G12C ---
A Study of LY3499446 in Participants With Advanced Solid Tumors With KRAS G12C Mutation The reason for this study is to see if the study drug LY3499446 is safe and effective in participants with solid tumors with KRAS G12C mutation. --- G12C --- --- G12C ---
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 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 Advanced Solid Tumor Non-Small Cell Lung Cancer Colorectal Cancer Carcinoma, Non-Small-Cell Lung Colorectal Neoplasms null --- G12C ---
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 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 Advanced Solid Tumor Non-Small Cell Lung Cancer Colorectal Cancer Carcinoma, Non-Small-Cell Lung Colorectal Neoplasms null --- G12C --- --- G12C ---