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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
12
Administered orally.
Jilin Cancer Hospital
Changchun, Jilin, China
The First Affiliated Hospital, Zhejiang University
Hangzhou, Zhejiang, China
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China
Pharmacokinetics (PK): Maximum Observed Plasma Concentration (Cmax) of LY3537982
PK: Cmax of LY3537982
Time frame: Predose approximately up to 18 weeks
PK: Area Under the Plasma Concentration Versus Time Curve (AUC) of LY3537982
PK: AUC of LY3537982
Time frame: Predose approximately up to 18 weeks
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).
Time frame: 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).
DCR: DCR assessed per Response Evaluation Criteria in Solid Tumors version 1.1 (RESIST v1.1).
Time frame: 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).
Time frame: First dose on day 1 approximately up to 3 years
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