Advanced Solid Tumors
Conditions
Keywords
Pharmacokinetics, Safety and Tolerability, Chinese
Brief summary
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.
Interventions
DRUGLY3537982
Administered orally.
Sponsors
Eli Lilly and Company
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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 central neural system (CNS) malignancy or metastasis and/or carcinomatous meningitis. * Have received prior treatment with any KRAS G12C small molecule inhibitor. * Females who are pregnant or lactating. * Have a known allergic reaction against any of the components of the study drug
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pharmacokinetics (PK): Maximum Observed Plasma Concentration (Cmax) of LY3537982 | Predose approximately up to 18 weeks | PK: Cmax of LY3537982 |
| PK: Area Under the Plasma Concentration Versus Time Curve (AUC) of LY3537982 | Predose approximately up to 18 weeks | PK: AUC of LY3537982 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Objective Response Rate (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 | 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). | First dose on day 1 approximately up to 3 years | 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). | First dose on day 1 approximately up to 3 years | PFS: PFS assessed per Response Evaluation Criteria in Solid Tumors version 1.1 (RESIST v1.1). |
Countries
China
Contacts
STUDY_DIRECTORCall 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
Outcome results
None listed