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| ID | Type | Description | Link |
|---|---|---|---|
| J3M-MC-JZQC | Other Identifier | Eli Lilly and Company |
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This is an open-label, single-arm, multicenter, Phase 1 study of LY3537982 as monotherapy in Chinese participants with KRAS G12C-mutant advanced solid tumors. The main purpose of this study is to determine how much of LY3537982 gets into the bloodstream and how long it takes the body to eliminate it in Chinese participants. The safety, tolerability and preliminary efficacy of LY3537982 will also be evaluated. Approximately 12 patients will be enrolled in this study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LY3537982 | Experimental | LY3537982 administered orally. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LY3537982 | Drug | Administered orally. |
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| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics (PK): Maximum Observed Plasma Concentration (Cmax) of LY3537982 | PK: Cmax of LY3537982 | Predose approximately up to 18 weeks |
| PK: Area Under the Plasma Concentration Versus Time Curve (AUC) of LY3537982 | PK: AUC of LY3537982 | Predose approximately up to 18 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate (ORR): ORR assessed per Response Evaluation Criteria in Solid Tumors version 1.1 (RESIST v1.1). | ORR: ORR assessed per Response Evaluation Criteria in Solid Tumors version 1.1 (RESIST v1.1). | First dose on day 1 approximately up to 3 years |
| Disease control rate (DCR): DCR assessed per Response Evaluation Criteria in Solid Tumors version 1.1 (RESIST v1.1). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) | Eli Lilly and Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jilin Cancer Hospital | Changchun | Jilin | 132000 | China | ||
| The First Affiliated Hospital, Zhejiang University |
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DCR: DCR assessed per Response Evaluation Criteria in Solid Tumors version 1.1 (RESIST v1.1). |
| First dose on day 1 approximately up to 3 years |
| Progression-free survival (PFS): PFS assessed per Response Evaluation Criteria in Solid Tumors version 1.1 (RESIST v1.1). | PFS: PFS assessed per Response Evaluation Criteria in Solid Tumors version 1.1 (RESIST v1.1). | First dose on day 1 approximately up to 3 years |
| Hangzhou |
| Zhejiang |
| 310003 |
| China |
| Zhejiang Cancer Hospital | Hangzhou | Zhejiang | 310022 | China |