A Study of LY3537982 in Chinese Participants With Advanced Solid Tumors

Phase 1

Active, not recruiting

• Conditions: Advanced Solid Tumors
• Interventions: Drug: LY3537982

• Registration Number: NCT06235983
• Lead Sponsor: Eli Lilly and Company

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-01-24
• Study First Submitted QC: 2024-01-24
• Study First Posted: 2024-02-01
• Study Start: 2024-02-29
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-17
• Last Update Posted: 2025-04-18
• Primary Completion: 2026-04
• Study Completion: 2027-04

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 12

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
LY3537982	LY3537982	LY3537982 administered orally.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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).
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).

Trial Locations

Locations (3)

Jilin Cancer Hospital; 🇨🇳 Changchun, Jilin, China

The First Affiliated Hospital, Zhejiang University; 🇨🇳 Hangzhou, Zhejiang, China

Zhejiang Cancer Hospital; 🇨🇳 Hangzhou, Zhejiang, China