NCT02923349已完成1 期
A Phase 1/2, Open-Label, Dose-Escalation, Safety and Tolerability Study of INCAGN01949 in Subjects With Advanced or Metastatic 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
- 87
- 试验地点
- 8
- 主要终点
- Number of Participants With Treatment-related Adverse Events
研究概览
简要总结
The purpose of this study is to determine the safety and tolerability and assess preliminary efficacy of INCAGN01949 in subjects with advanced or metastatic solid tumors.
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
- •Locally advanced or metastatic disease; locally advanced disease must not be amenable to resection with curative intent.
- •Subjects who have disease progression after treatment with available therapies that are known to confer clinical benefit, or who are intolerant to treatment, or who refuse standard treatment. There is no limit to the number of prior treatment regimens.
- •Part 1: Subjects with advanced or metastatic solid tumors.
- •Part 2: Subjects with advanced or metastatic adenocarcinoma of the endometrium, ovarian cancer, renal cell carcinoma, melanoma, and non-small cell lung cancer.
- •Presence of measureable disease based on RECIST v1.
- •Eastern Cooperative Oncology Group performance status 0 or 1.
排除标准
- •Laboratory and medical history parameters not within the protocol-defined range.
- •Receipt of anticancer medications or investigational drugs within the protocol-defined intervals before the first administration of study drug.
- •Has not recovered to ≤ Grade 1 from toxic effects of prior therapy (including prior immunotherapy) and/or complications from prior surgical intervention before starting therapy.
- •Receipt of a live vaccine within 30 days of planned start of study drug.
- •Active autoimmune disease that required systemic treatment in the past.
研究组 & 干预措施
INCAGN01949
Experimental
干预措施: INCAGN01949 (Drug)
结局指标
主要结局
Number of Participants With Treatment-related Adverse Events
时间窗: From screening through 60 days after end of treatment, up to 11 months
Adverse events reported for the first time or worsening of a pre-existing event after first dose of study drug/treatment
次要结局
- Maximum Observed Concentration (Cmax) of INCAGN01949 in Plasma(Pre-infusion for cycles 1,2,3,4,5,6 and 7, 10-minutes, 4 hrs, 24 hrs post-infusion, Day 8 for cycles 1 & 6)
- Area Under the Single-dose Concentration-time Curve (AUC0-t) of INCAGN01949(Pre-infusion for cycles 1,2,3,4,5,6 and 7, 10-minutes, 4 hrs, 24 hrs post-infusion, Day 8 for cycles 1 & 6)
- Objective Response Rate Per RECIST and Modified RECIST(Baseline and every 8 weeks,up to 11 months)
- Duration of Response Per RECIST and Modified RECIST(Baseline and every 8 weeks, up to 11 months)
- Progression-free Survival Per RECIST and Modified RECIST(Baseline and every 8 weeks, up to 11 months)
- Duration of Disease Control Per RECIST and Modified RECIST(Baseline and every 8 weeks, up to 11 months)
- Time to Maximum Concentration of INCAGN01949 in Plasma(Pre-infusion for cycles 1,2,3,4,5,6 and 7, 10-minutes, 4 hrs, 24 hrs post-infusion, Day 8 for cycles 1 & 6)
- Summary of Trough Concentrations(Cmin) of INCAGN01949(Pre-infusion for cycles 1,2,3,4,5,6 and 7, 10-minutes, 4 hrs, 24 hrs post-infusion, Day 8 for cycles 1 & 6)
研究者
研究点 (8)
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