NCT03099109已完成1 期
A Phase 1a/1b Study of LY3321367, an Anti-TIM-3 Antibody, Administered Alone or in Combination With LY3300054, an Anti-PD-L1 Antibody, in Advanced Relapsed/Refractory Solid Tumors
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 209
- 试验地点
- 15
- 主要终点
- Number of Participants with DLTs
研究概览
简要总结
The purpose of this study is to evaluate the safety of the study drug known as LY3321367, an anti-T-cell immunoglobulin and mucin-domain domain-containing molecule-3 (TIM-3) antibody administered alone or in combination with LY3300054, an anti-programmed death ligand 1 (PD-L1) antibody, in participants with advanced relapsed/refractory solid tumors.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 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
- •For Ph1a monotherapy and combination cohorts, histologic or cytologic confirmation of advanced solid tumor.
- •For Phase 1a and 1b, prior PD-1 or PD-L1 therapy or other immunotherapy is allowed, if the following criteria are met:
- •Must not have experienced a toxicity that led to permanent discontinuation of prior immunotherapy.
- •Must have completely recovered or recovered to baseline prior to screening from any prior AEs occurring while receiving prior immunotherapy.
- •Must have provided tumor tissue sample, as follows:
- •For participants entering Ph1a: have submitted, if available, an archival tumor tissue sample.
- •For participants entering Ph1b: have submitted, a sample from a newly obtained core or excisional biopsy of a tumor lesion or a recent biopsy defined by 6 months of study enrollment (Ph1b).
- •Must have a performance status of 0 to 1 on the Eastern Cooperative Oncology Group (ECOG) scale.
- •Must have adequate organ function.
- •Have an estimated life expectancy of 12 weeks, in judgement of the investigator.
排除标准
- •Have symptomatic or uncontrolled brain metastases, spinal cord compression, or leptomeningeal disease requiring concurrent treatment, including but not limited to surgery, radiation, and/or corticosteroids (participants receiving anticonvulsants are eligible).
- •Have received a live vaccine within 30 days before the first dose of study treatment.
- •If female, is pregnant, breastfeeding, or planning to become pregnant.
- •Have a history or current evidence of any condition, therapy, or laboratory abnormality that might interfere with the participant's participation.
- •Have moderate or severe cardiovascular disease.
- •Have a serious concomitant systemic disorder that would compromise the participant's ability to adhere to the protocol, including active or chronic infection with human immunodeficiency virus (HIV), active hepatitis B virus (HBV), active hepatitis C virus (HCV), active autoimmune disorders, or prior documented severe autoimmune or inflammatory disorders requiring immunosuppressive treatment.
- •Use of escalating or chronic supraphysiologic doses of corticosteroids or immunosuppressive agents (such as, cyclosporine). [Use of topical, ophthalmic, inhaled, and intranasal corticosteroids permitted].
- •Bowel obstruction, history or presence of inflammatory enteropathy or extensive intestinal resection.
- •Evidence of interstitial lung disease or noninfectious pneumonitis.
研究组 & 干预措施
Japanese Arm F LY3321367 + LY3300054
Experimental
LY3321367 and LY3300054 given IV.
干预措施: LY3321367 (Drug)
LY3321367 + LY3300054 Dose Escalation
Experimental
LY3321367 and LY3300054 given IV.
干预措施: LY3300054 (Drug)
LY3321367 Dose Escalation
Experimental
LY3321367 given intravenously (IV).
干预措施: LY3321367 (Drug)
LY3321367 + LY3300054 Dose Escalation
Experimental
LY3321367 and LY3300054 given IV.
干预措施: LY3321367 (Drug)
LY3321367 Dose Expansion
Experimental
LY3321367 given IV.
干预措施: LY3321367 (Drug)
LY3321367 + LY3300054 Dose Expansion
Experimental
LY3321367 and LY3300054 given IV.
干预措施: LY3321367 (Drug)
LY3321367 + LY3300054 Dose Expansion
Experimental
LY3321367 and LY3300054 given IV.
干预措施: LY3300054 (Drug)
Japanese Arm D LY3321367
Experimental
LY3321367 given IV.
干预措施: LY3321367 (Drug)
Japanese Arm E LY3300054
Experimental
LY3300054 given IV.
干预措施: LY3300054 (Drug)
Japanese Arm F LY3321367 + LY3300054
Experimental
LY3321367 and LY3300054 given IV.
干预措施: LY3300054 (Drug)
结局指标
主要结局
Number of Participants with DLTs
时间窗: Baseline through Cycle 1 (28 Day Cycle)
Dose Limiting Toxicity (DLT) is defined as an adverse event (AE) that meets protocol defined DLT criteria during cycle 1 and is at least possibly related to study drug.
次要结局
- TTR(Baseline to Date of CR or PR (Estimated up to 6 Months))
- PK: Cmax of LY3321367(Cycle 1 Day 1 through Follow-Up (Estimated up to 6 Months))
- DCR: Percentage of Participants who Exhibit SD, CR or PR(Baseline through Measured Progressive Disease (Estimated up to 6 Months))
- PK: Cmax of LY3321367 in Combination with LY3300054(Cycle 1 Day 1 through Follow-Up (Estimated up to 6 Months))
- ORR: Percentage of Participants With a CR or PR(Baseline to Measured Progressive Disease (Estimated up to 6 Months))
- PFS(Baseline to Objective Progression or Death Due to Any Cause (Estimated Up to 12 Months))
- DoR(Date of CR or PR to Date of Objective Progression or Death Due to Any Cause (Estimated up to 12 Months))
研究者
研究点 (15)
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