A Phase 1a/1b Study of an Anti-IDO-1 Agent (LY3381916) Administered Alone or in Combination With Anti- PD-L1 Checkpoint Antibody (LY3300054) in Solid Tumors
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 60
- 试验地点
- 12
- 主要终点
- Number of Participants with Dose Limiting Toxicities (DLTs)
研究概览
简要总结
The purpose of this study is to evaluate the safety of the study drug LY3381916 administered alone or in combination with anti-programmed cell death ligand 1 (PD-L1) checkpoint antibody (LY3300054).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- •Dose escalation phase: Participant must have histological or cytological evidence of a diagnosis of cancer that is advanced and/or metastatic.
- •Dose expansion B1: Metastatic TNBC participants who have not received prior PD-1/L1 treatment.
- •Dose expansion B2: Metastatic NSCLC participants who have progressed on prior PD-L1/L1 treatment.
- •Dose expansion B3: Metastatic clear cell carcinoma RCC who have progressed on prior PD-L1/L1 treatment.
- •Have adequate organ function.
- •Have a performance status (PS) of ≤1 on the Eastern Cooperative Oncology Group (ECOG) scale.
- •Are able and willing to provide required, newly acquired tumor biopsies.
- •Have discontinued previous treatments for cancer.
- •Are able to swallow capsules.
排除标准
- •Currently enrolled in a clinical study.
- •Have known symptomatic central nervous system metastases or carcinomatous meningitis.
- •Have a serious concomitant systemic disorder.
- •Have a symptomatic human immunodeficiency virus infection or symptomatic activated/reactivated hepatitis B or C.
- •Have a significant cardiac condition.
- •Have previously received an indoleamine- 2,3-dioxygenase (IDO) inhibitor.
- •Have an active autoimmune disease or currently require immunosuppression of >10 milligrams of prednisone or equivalent per day.
- •Have interstitial lung disease or (noninfectious) pneumonitis, participants with a history of (noninfectious) pneumonitis that required steroids to assist with management.
研究组 & 干预措施
LY3381916 Escalation
LY3381916 administered orally.
干预措施: LY3381916 (Drug)
LY3381916 + LY3300054 Escalation
LY3381916 administered orally and LY3300054 administered intravenously (IV).
干预措施: LY3381916 (Drug)
LY3381916 + LY3300054 Escalation
LY3381916 administered orally and LY3300054 administered intravenously (IV).
干预措施: LY3300054 (Drug)
LY3381916 Expansion
LY3381916 administered orally.
干预措施: LY3381916 (Drug)
LY3381916 + LY3300054 Expansion B1
Metastatic triple negative breast cancer (TNBC)
LY3381916 administered orally and LY3300054 administered IV.
干预措施: LY3381916 (Drug)
LY3381916 + LY3300054 Expansion B1
Metastatic triple negative breast cancer (TNBC)
LY3381916 administered orally and LY3300054 administered IV.
干预措施: LY3300054 (Drug)
LY3381916 + LY3300054 Expansion B2
Metastatic non-small cell lung cancer (NSCLC)
LY3381916 administered orally and LY3300054 administered IV.
干预措施: LY3381916 (Drug)
LY3381916 + LY3300054 Expansion B2
Metastatic non-small cell lung cancer (NSCLC)
LY3381916 administered orally and LY3300054 administered IV.
干预措施: LY3300054 (Drug)
LY3381916 + LY3300054 Expansion B3
Metastatic clear cell carcinoma renal cell carcinoma (RCC)
LY3381916 administered orally and LY3300054 administered IV.
干预措施: LY3381916 (Drug)
LY3381916 + LY3300054 Expansion B3
Metastatic clear cell carcinoma renal cell carcinoma (RCC)
LY3381916 administered orally and LY3300054 administered IV.
干预措施: LY3300054 (Drug)
结局指标
主要结局
Number of Participants with Dose Limiting Toxicities (DLTs)
时间窗: Baseline through Cycle 1 (28 Day Cycle)
Number of participants with DLTs
次要结局
- Pharmacokinetics (PK): Maximum Plasma Concentration (Cmax) of LY3381916(Predose Lead in Day 1 through Cycle 3 Day 1)
- PK: Area Under the Plasma Concentration Curve (AUC) of LY3381916(Predose Lead in Day 1 through Cycle 3 Day 1)
- PK: Cmax of LY3381916 Administered in Combination with LY3300054(Predose Cycle 1 Day 1 through Cycle 3 Day 1)
- PK: AUC of LY3381916 Administered in Combination with LY3300054(Predose Cycle 1 Day 1 through Cycle 3 Day 1)
- PK: Cmax of LY3300054 Administered in Combination with LY3381916(Predose Cycle 1 Day 1 through Cycle 3 Day 1)
- PK: Minimum Plasma Concentration (Cmin) of LY3300054 Administered in Combination with LY3381916(Predose Cycle 1 Day 1 through Cycle 3 Day 1)
- Objective Response Rate (ORR): Percentage of Participants with a Complete Response (CR) or Partial Response (PR)(Baseline through Measured Progressive Disease (Estimated up to 12 Months))
- Time to Response (TTR)(Baseline to Date of CR or PR (Estimated up to 12 Months))
- Disease Control Rate (DCR): Percentage of Participants who Exhibit Stable Disease (SD), CR or PR(Baseline through Measured Progressive Disease (Estimated up to 12 Months))
- Duration of Response (DOR)(Date of CR or PR to Date of Objective Progression or Death Due to Any Cause (Estimated up to 12 Months))
- Progression Free Survival (PFS)(Baseline to Objective Progression or Death Due to Any Cause (Estimated Up to 12 Months))