Description:
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.
Title
- Brief Title: A Study of LY3499446 in Participants With Advanced Solid Tumors With KRAS G12C Mutation
- Official Title: A Phase 1/2 Study of LY3499446 Administered to Patients With Advanced Solid Tumors With KRAS G12C Mutation
Clinical Trial IDs
- ORG STUDY ID:
17501
- SECONDARY ID:
J2K-MC-JZKA
- SECONDARY ID:
2019-003070-53
- NCT ID:
NCT04165031
Conditions
- Advanced Solid Tumor
- Non-Small Cell Lung Cancer
- Colorectal Cancer
Interventions
| Drug | Synonyms | Arms |
|---|
| LY3499446 | | LY3499446 + Abemaciclib Phase 1 |
| Abemaciclib | LY2835219 | LY3499446 + Abemaciclib Phase 1 |
| Cetuximab | | LY3499446 + Cetuximab Phase 1 |
| Erlotinib | | LY3499446 + Erlotinib Phase 1 |
| Docetaxel | | Docetaxel Phase 2 |
Purpose
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.
Trial Arms
| Name | Type | Description | Interventions |
|---|
| LY3499446 Phase 1 | Experimental | Participants given LY3499446 monotherapy orally. | |
| LY3499446 + Abemaciclib Phase 1 | Experimental | Participants given LY3499446 and abemaciclib orally. | |
| LY3499446 + Cetuximab Phase 1 | Experimental | Participants given LY3499446 orally and cetuximab intravenously (IV). | |
| LY3499446 + Erlotinib Phase 1 | Experimental | Participants given LY3499446 and erlotinib orally. | |
| LY3499446 Phase 2 | Experimental | Participants given LY3499446 monotherapy orally. | |
| LY3499446 + Abemaciclib Phase 2 | Experimental | Participants given LY3499446 and abemaciclib orally. | |
| LY3499446 + Erlotinib Phase 2 | Experimental | Participants given LY3499446 and erlotinib orally. | |
| LY3499446 + Cetuximab Phase 2 | Experimental | Participants given LY3499446 orally and cetuximab IV. | |
| Docetaxel Phase 2 | Active Comparator | Participants given docetaxel IV. | |
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
| Maximum Eligible Age: | N/A |
| Minimum Eligible Age: | 18 Years |
| Eligible Gender: | All |
| Healthy Volunteers: | No |
Primary Outcome Measures
| Measure: | Phase 1: Number or Participants with Dose Limiting Toxicities (DLTs) |
| Time Frame: | Cycle 1 (21 Day Cycle) |
| Safety Issue: | |
| Description: | Phase 1: Number or Participants with DLTs |
Secondary Outcome Measures
| Measure: | Pharmacokinetics (PK): Average Concentration at Steady State of LY3499446 |
| Time Frame: | Predose Cycle 1 Day 1 through Cycle 3 Day 1 (21 Day Cycles) |
| Safety Issue: | |
| Description: | PK: Average Concentration at Steady State of LY3499446 |
| Measure: | PK: Average Concentration at Steady State of LY3499446 in Combination with Abemaciclib |
| Time Frame: | Predose Cycle 1 Day 1 through Cycle 3 Day 1 (21 Day Cycles) |
| Safety Issue: | |
| 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 Cetuximab |
| Time Frame: | Predose Cycle 1 Day 1 through Cycle 3 Day 1 (21 Day Cycles) |
| Safety Issue: | |
| 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 Erlotinib |
| Time Frame: | Predose Cycle 1 Day 1 through Cycle 3 Day 1 (21 Day Cycles) |
| Safety Issue: | |
| Description: | PK: Average Concentration at Steady State of LY3499446 in Combination with Erlotinib |
| Measure: | Phase 1: ORR: Percentage of Participants Who Achieve CR or PR |
| Time Frame: | Baseline through Measured Progressive Disease (Estimated up to 24 Months) |
| Safety Issue: | |
| Description: | Phase 1: ORR: Percentage of Participants Who Achieve CR or PR |
| Measure: | Phase 1: PFS |
| Time Frame: | Baseline to Objective Progression or Death Due to Any Cause (Estimated up to 24 Months) |
| Safety Issue: | |
| Description: | Phase 1: PFS |
| Measure: | Duration of Response (DoR) |
| Time Frame: | Date of CR or PR to Date of Disease Progression or Death Due to Any Cause (Estimated up to 24 Months) |
| Safety Issue: | |
| Description: | DoR |
| Measure: | Disease Control Rate (DCR): Percentage of Participants with a Best Overall Response of CR, PR, and SD |
| Time Frame: | Baseline through Measured Progressive Disease (Estimated up to 24 Months) |
| Safety Issue: | |
| Description: | Disease Control Rate (DCR): Percentage of Participants with a Best Overall Response of CR, PR, and SD |
Details
| Phase: | Phase 1/Phase 2 |
| Primary Purpose: | Interventional |
| Overall Status: | Terminated |
| Lead Sponsor: | Eli Lilly and Company |
Last Updated
December 9, 2020
