A Study of LY3537982 in Chinese Participants With Advanced Solid Tumors

NCT ID: NCT06235983

Last Updated: 2025-04-18

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-02-29
• Study Completion Date: 2027-04-30

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.

Conditions

Advanced Solid Tumors

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

LY3537982

LY3537982 administered orally.

Group Type: EXPERIMENTAL

LY3537982

Intervention Type: DRUG

Administered orally.

Interventions

LY3537982

Administered orally.

Intervention Type: DRUG

Other Intervention Names

Olomorasib

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 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Eli Lilly and Company

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

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)

Role: STUDY_DIRECTOR

Eli Lilly and Company

Locations

Jilin Cancer Hospital

Changchun, Jilin, China

The First Affiliated Hospital, Zhejiang University

Hangzhou, Zhejiang, China

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, China

Countries

China

Other Identifiers

J3M-MC-JZQC

Identifier Type: OTHER

Identifier Source: secondary_id

18737

Identifier Type: -

Identifier Source: org_study_id