NCT02221882已完成1 期
A Phase 1 Study of LY3164530, a Bispecific Antibody Targeting Mesenchymal-Epithelial Transition Factor (MET) and Epidermal Growth Factor Receptor (EGFR), in Patients With Advanced or Metastatic Cancer
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
- 29
- 试验地点
- 3
- 主要终点
- Recommended Phase 2 Dose of LY3164530: Maximum Tolerated Dose (MTD)
研究概览
简要总结
The main purpose of this study is to evaluate the safety of a study drug known as LY3164530 in participants with cancer that is advanced and/or has spread to another part(s) of the body.
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
- 未提供
排除标准
- •Must not have taken an unapproved drug as treatment for any indication within the last 28 days prior to starting study treatment.
- •Must not have an active symptomatic fungal, bacterial or viral infection, including human immunodeficiency virus (HIV) or Hepatitis A, B, or C.
- •Must not have a serious preexisting medical conditions or concomitant disorders.
- •Must not have leukemia.
- •Must not have QT interval of >470 millisecond.
- •Must not have a serious cardiac condition, such as congestive heart failure, unstable angina pectoris, or heart attack within the last 3 months.
研究组 & 干预措施
LY3164530
Experimental
LY3164530 in escalating dose cohorts given intravenously (IV) once on Days 1 and 15 or on Days 1, 8, 15, and 22 of a 28-day cycle. Participants may continue to receive study drug until discontinuation criteria are met.
干预措施: LY3164530 (Drug)
结局指标
主要结局
Recommended Phase 2 Dose of LY3164530: Maximum Tolerated Dose (MTD)
时间窗: Cycle 1 (Cycle = 28 days)
Recommended Phase 2 Dose of LY3164530: MTD
次要结局
- Area Under the Serum Concentration-Time Curve (AUC[0-τ]) of LY3164530 EGFR Specific ELISA Assay(Cycle 1 predose (Day 1) up to Cycle 6 end of infusion (Day 1))
- Number of Participants With Tumor Response(Baseline Through Study Completion (Up to 6 Months))
- Maximum Serum Concentration (Cmax) of LY3164530 Mesenchymal-Epithelial Transition Factor (MET) Specific ELISA Assay(Cycle 1 predose (Day 1) up to Cycle 6 end of infusion (Day 1))
- Maximum Serum Concentration (Cmax) of LY3164530 Epidermal Growth Factor Receptor (EGFR) Specific ELISA Assay(Cycle 1 predose (Day 1) up to Cycle 6 end of infusion (Day 1))
- Area Under the Serum Concentration-Time Curve (AUC[0-τ]) of LY3164530 MET Specific ELISA Assay(Cycle 1 predose (Day 1) up to Cycle 6 end of infusion (Day 1))
研究者
研究点 (3)
Loading locations...
相似试验
终止
1 期
A Study of LY3434172, a PD-1 and PD-L1 Bispecific Antibody, in Advanced CancerAdvanced CancerNCT03936959Eli Lilly and Company10
招募中
1 期
A Study of LY4052031 in Participants With Advanced or Metastatic Urothelial Cancer or Other Solid TumorsMetastatic Solid TumorRecurrent Solid TumorAdvanced Solid TumorUrinary Bladder NeoplasmTriple Negative Breast CancerHead and Neck Squamous Cell CarcinomaRenal Pelvis CancerProstate CancerPancreatic CancerNon-small Cell Lung CancerBladder CancerEsophageal CancerCervical CancerOvarian CancerNCT06465069Eli Lilly and Company420
已完成
1 期
A Study of LY3039478 in Combination With Dexamethasone in Participants With T-ALL/T-LBLT-cell Acute Lymphoblastic LeukemiaT-cell Lymphoblastic LymphomaNCT02518113Eli Lilly and Company36
终止
1 期
A Study of LY3415244 in Participants With Advanced Solid TumorsSolid TumorNCT03752177Eli Lilly and Company12
终止
1 期
A Study of LY3039478 in Participants With Advanced or Metastatic Solid TumorsSolid TumorSoft Tissue SarcomaBreast CancerColon CancerCholangiocarcinomaNCT02784795Eli Lilly and Company94