A Phase 1, First-in-Human, Dose-Finding and Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Activity of XmAb®808 in Combination With Pembrolizumab in Selected Advanced Solid Tumors
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Xencor, Inc.
- 入组人数
- 60
- 试验地点
- 12
- 主要终点
- Incidence of treatment-emergent adverse events (TEAEs)
研究概览
简要总结
The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of intravenous (IV) administration of XmAb808 in combination with pembrolizumab in subjects with selected advanced solid tumors and to identify the minimum safe and biologically effective/recommended dose (RD) and schedule for XmAb808.
详细描述
This is a Phase 1, open-label, first-in-human (FIH), multiple-dose, dose escalation study with cohort expansion at the RD, designed to evaluate the safety and tolerability of XmAb808 in combination with pembrolizumab. This study will be conducted in 2 parts: Part A (dose escalation) and Part B (cohort expansion).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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
- •Part A: Histologically confirmed advanced/metastatic castration-resistant prostate adenocarcinoma, epithelial ovarian cancer, head and neck squamous cell carcinoma, non-small cell lung cancer, urothelial carcinoma, melanoma, renal cell carcinoma, triple-negative breast cancer, or colorectal cancer that has progressed on standard therapies
- •Part B: Histologically confirmed advanced/metastatic castration-resistant prostate cancer that is PD1-naïve; head and neck squamous cell carcinoma that is PD1-naïve or has progressed on prior PD1 therapy; or melanoma that is PD1-naïve or has progressed on prior PD1 therapy
- •Measurable disease by RECIST 1.1; subjects with prostate cancer who have evaluable disease according to PCWG3 criteria may enroll
- •Life expectancy > 3 months
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
排除标准
- •Subjects currently receiving other anticancer therapies
- •Any prior treatment with an investigational agent targeting CD28
- •History of a life-threatening adverse event related to prior immunotherapy
- •Known active central nervous system involvement by malignant disease. Subjects with previously treated brain metastases may participate provided they are radiologically and clinically stable
研究组 & 干预措施
Dose Escalation and Expansion XmAb®808 administered in combination with pembrolizumab
XmAb®808 in combination with pembrolizumab
干预措施: XmAb®808 (Biological)
Dose Escalation and Expansion XmAb®808 administered in combination with pembrolizumab
XmAb®808 in combination with pembrolizumab
干预措施: Keytruda® (pembrolizumab) (Biological)
结局指标
主要结局
Incidence of treatment-emergent adverse events (TEAEs)
时间窗: Up to 5 years
Safety and tolerability as assessed by incidence of TEAEs, including clinically significant changes in safety laboratory tests and clinical findings
Incidence of dose-limiting toxicities (DLTs)
时间窗: 49 days
Safety and tolerability as assessed by incidence of DLTs and all available data which will be used to determine the optimal dose regimen
次要结局
- Measurement of Cmax(Through study completion, Up to 5 years)
- Objective Response Rate(Through study completion, Up to 5 years)
- Progression-free Survival(Through study completion, Up to 5 years)
- Duration of Response(Through study completion, Up to 5 years)
- Measurement of AUCtau(Through study completion, Up to 5 years)