A Phase I Study of the Anti-C5aR, IPH5401, in Combination With the Anti-PD-L1, Durvalumab, in Patients With Selected Advanced Solid Tumors
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 73
- 试验地点
- 12
- 主要终点
- Adverse events (AEs)
研究概览
简要总结
This is a multicenter, open-label, dose-escalation and dose-expansion study to evaluate the safety, tolerability, antitumor activity of IPH5401 (anti C5aR) in combination with Durvalumab (MEDI4736) in Adult Subjects with selected advanced 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
- •Patients with advanced and/or metastatic histologically solid tumors with evidence of active disease, who have been treated with a minimum of one line of systemic therapy in the metastatic setting, and in expansion part, no more than two prior systemic therapies.
- •At least 18 years of age.
- •ECOG performance status of ≤
- •Adequate organ function
排除标准
- •For patients with Non Small Cell Lung Cancer (NSCLC):
- •a. Known actionable mutation or rearrangement (including but not limited to the epidermal growth factor receptor (EGFR), anaplastic lymphoma kinase (ALK) gene rearrangements, ROS-1 alterations or BRAF mutations)
- •For patient with Hepatocellular carcinoma (HCC):
- •Hepatic encephalopathy in the past 12 months.
- •Ascites that requires repeated paracentesis in the past 2 months.
- •Main portal vein thrombosis.
- •Active or prior history of gastrointestinal bleeding in the past 12 months.
- •Prior hepatic transplantation.
- •Patients with known spinal cord compression.
- •Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases.
研究组 & 干预措施
Dose escalation
IPH5401 at different doses and schedule + Durvalumab
干预措施: IPH5401 and Durvalumab (Biological)
Cohort expansion NSCLC anti-PD-(L)1 pretreated
IPH5401 at recommended dose and schedule + Durvalumab in NSCLC anti-PD-(L)1 pretreated patients
干预措施: IPH5401 and Durvalumab (Biological)
Cohort expansion HCC anti-PD-(L)1 naive
IPH5401 at recommended dose and schedule + Durvalumab in HCC anti-PD-(L)1 naive patients
干预措施: IPH5401 and Durvalumab (Biological)
Cohort expansion HCC anti-PD-(L)1 pretreated
IPH5401 at recommended dose and schedule + Durvalumab in HCC anti-PD-(L)1 pretreated patients
干预措施: IPH5401 and Durvalumab (Biological)
结局指标
主要结局
Adverse events (AEs)
时间窗: From screening visit up to 30 days after the last dose of study medication
To evaluate the safety profile
Occurrence of Drug Limited Toxicities (DLTs)
时间窗: From Time of First dose assessed up to 6 weeks
To assess the occurrence of Drug Limited Toxicities (DLTs)
次要结局
- Objective Response Rate(up to 12 months)
- Progression Free Survival(2 years and 9 months)
- Duration of Response(2 years and 9 months)