A Study of LY3537982 in Chinese Participants With Advanced Solid Tumors

Last updated: April 17, 2025
Sponsor: Eli Lilly and Company
Overall Status: Active - Not Recruiting

Phase

1

Condition

Neoplasms

Treatment

LY3537982

Clinical Study ID

NCT06235983
18737
J3M-MC-JZQC
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Native Chinese participants must be of an acceptable age to provide informedconsent.

  • 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 studytreatment.

  • 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

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 participationin this study.

  • Have a serious cardiac condition.

  • Have untreated active symptomatic central neural system (CNS) malignancy ormetastasis 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

Total Participants: 12
Treatment Group(s): 1
Primary Treatment: LY3537982
Phase: 1
Study Start date:
February 29, 2024
Estimated Completion Date:
April 30, 2027

Connect with a study center

  • Harbin Medical University Cancer Hospital

    Harbin, Heilongjiang 150081
    China

    Site Not Available

  • Hunan Cancer Hospital

    Changsha, Hunan 410013
    China

    Site Not Available

  • Jilin Cancer Hospital

    Changchun, Jilin 132000
    China

    Site Not Available

  • Jilin Province Tumor Hospital

    Changchun, Jilin 130028
    China

    Site Not Available

  • Jinan Central Hospital

    Jinan, Shandong 250013
    China

    Site Not Available

  • Shanghai Chest Hospital

    Shanghai, Shanghai 200030
    China

    Site Not Available

  • The First Affiliated Hospital, Zhejiang University

    Hangzhou, Zhejiang 310003
    China

    Site Not Available

  • The first Affiliated Hospital, Zhejiang University School of Medicine

    Hangzhou, Zhejiang 310003
    China

    Site Not Available

  • Zhejiang Cancer Hospital

    Hangzhou, Zhejiang 310022
    China

    Site Not Available

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