A Study of LY3537982 in Chinese Participants With Advanced Solid Tumors

Lilly

Status and phase

Active, not recruiting

Phase 1

Conditions

Advanced Solid Tumors

Treatments

Drug: LY3537982

Study type

Interventional

Funder types

Industry

Identifiers

NCT06235983

J3M-MC-JZQC (Other Identifier)

18737

Details and patient eligibility

About

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.

Enrollment

12 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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