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
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 3
- 主要终点
- Pharmacokinetics (PK): Maximum Observed Plasma Concentration (Cmax) of LY3537982
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •- 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
- •Have adequate laboratory parameters.
- •Must be able to swallow capsules or tablets.
- •Estimated life expectancy ≥12 weeks
排除标准
- •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
研究组 & 干预措施
LY3537982
LY3537982 administered orally.
干预措施: LY3537982 (Drug)
结局指标
主要结局
Pharmacokinetics (PK): Maximum Observed Plasma Concentration (Cmax) of LY3537982
时间窗: Predose approximately up to 18 weeks
PK: Cmax of LY3537982
PK: Area Under the Plasma Concentration Versus Time Curve (AUC) of LY3537982
时间窗: Predose approximately up to 18 weeks
PK: AUC of LY3537982
次要结局
- 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)
- 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)
- 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)