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Completed

NCT Number: NCT06235983

A Study of LY3537982 in Chinese Participants With Advanced Solid Tumors

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Jilin Cancer Hospital, Changchun, Jilin, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

LY3537982

Drug

Administered orally.

Other names: Olomorasib

Primary outcomes

  1. Pharmacokinetics (PK): Maximum Observed Plasma Concentration (Cmax) of LY3537982

    Time frame: Predose approximately up to 18 weeks

    PK: Cmax of LY3537982

  2. PK: Area Under the Plasma Concentration Versus Time Curve (AUC) of LY3537982

    Time frame: Predose approximately up to 18 weeks

    PK: AUC of LY3537982

Secondary outcomes

  1. Objective Response Rate (ORR): ORR assessed per Response Evaluation Criteria in Solid Tumors version 1.1 (RESIST v1.1).

    Time frame: 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).

  2. Disease control rate (DCR): DCR assessed per Response Evaluation Criteria in Solid Tumors version 1.1 (RESIST v1.1).

    Time frame: 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).

  3. Progression-free survival (PFS): PFS assessed per Response Evaluation Criteria in Solid Tumors version 1.1 (RESIST v1.1).

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

An Open-label, Single-arm, Multicenter, Phase 1 Study to Investigate the Pharmacokinetics, Safety, Tolerability, and Antitumor Activity of LY3537982 in Chinese Patients With KRAS G12C-Mutant Advanced Solid Tumors

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Feb 1, 2024
Registry last updated
May 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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