A Study of LY3537982 in Chinese Participants With Advanced Solid Tumors
An Open-label, Single-arm, Multicenter, Phase 1 Study to Investigate the Pharmacokinetics, Safety, Tolerability, and Antitumor Activity of LY3537982 in Chinese Patients With KRAS G12C-Mutant Advanced Solid Tumors
Sponsor: Eli Lilly and Company
No open prediction endpoints
Endpoints are classified and published by ProgramSignal analysts.
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Primary Endpoints (CT.gov)
Pharmacokinetics (PK): Maximum Observed Plasma Concentration (Cmax) of LY3537982
Time frame: Predose approximately up to 18 weeks
PK: Area Under the Plasma Concentration Versus Time Curve (AUC) of LY3537982
Time frame: Predose approximately up to 18 weeks
Secondary Endpoints
Objective Response Rate (ORR): ORR assessed per Response Evaluation Criteria in Solid Tumors version 1.1 (RESIST v1.1).
Disease control rate (DCR): DCR assessed per Response Evaluation Criteria in Solid Tumors version 1.1 (RESIST v1.1).
Progression-free survival (PFS): PFS assessed per Response Evaluation Criteria in Solid Tumors version 1.1 (RESIST v1.1).
Eligibility Criteria
Inclusion Criteria: * \- Native Chinese participants must be of an acceptable age to provide informed consent. * Have measurable disease per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST version 1.1). * Have disease with evidence of KRAS G12C mutation * Have a histologically or cytologically proven diagnosis of locally advanced, unresectable, and/or metastatic cancer and must be appropriate candidates for study treatment. * Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. * Have adequate laboratory parameters. * Must be able to swallow capsules or tablets. * Estimated life expectancy ≥12 weeks Exclusion Criteria: * Have disease suitable for local therapy administered with curative intent. * Have an active fungal, bacterial, and/or active untreated viral infection, * Have a serious pre-existing medical condition(s) that would preclude participation in this study. * Have a serious cardiac condition. * Have untreated active symptomatic …
Read full criteria on CT.gov →✦ Analyst Commentary
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