A Phase 1 Dose Escalation With Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of AMV564 Alone and in Combination With Pembrolizumab in Subjects With Advanced Solid Tumors
试验速览
- 阶段
- 1 期
- 入组人数
- 65
- 试验地点
- 22
- 主要终点
- Maximum tolerated dose of AMV564 in subjects with advanced solid tumors
研究概览
简要总结
This Phase 1 study is designed to assess the safety, tolerability, pharmacokinetics, and preliminary efficacy of AMV564 alone and in combination with Pembrolizumab in patients with advanced solid tumors.
详细描述
AMV564-301 is a Phase 1, open-label, multicenter dose-escalation with expansion trial in patients with locally advanced or metastatic solid tumors. In the dose-escalation portion of the study, cohorts of patients will receive AMV564 alone or in combination with Pembrolizumab at increasing dose levels to determine the maximum tolerated dose (MTD) and/or the recommended dose for expansion. In the expansion portion of the study, one or more cohorts of patients will receive AMV564 at the MTD or recommended dose to further evaluate safety, tolerability, and clinical activity.
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
- •18 years of age or older
- •Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
- •Histologically or cytologically documented, incurable or metastatic solid tumor that is advanced (non-resectable) or recurrent and progressing since the last anti-tumor therapy and for which no recognized standard therapy exists
- •Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 or per other criteria best suited for the specific tumor type being evaluated
- •Willing to complete all scheduled visits and assessments at the institution administering therapy
排除标准
- •Treatment with any local or systemic antineoplastic therapy (including chemotherapy, hormonal therapy, or radiation) within 3 weeks prior to first dose of AMV564
- •Major trauma or major surgery within 4 weeks prior to first dose of AMV564
- •Prior treatment with chimeric antigen receptor (CAR) T-cell therapy or T-cell engager therapy
- •Chronic use of corticosteroids in excess of 10 mg daily of prednisone or equivalent within 4 weeks prior to first dose of AMV564
- •Adverse events from prior anti-cancer therapy that have not resolved to Grade ≤ 1 except for alopecia
- •Known, central nervous system (CNS) disease involvement, or prior history of National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE) Grade ≥ 3 drug-related CNS toxicity
结局指标
主要结局
Maximum tolerated dose of AMV564 in subjects with advanced solid tumors
时间窗: During Dose Escalation, an average of 6 months
As determined based on the occurrence of dose-limiting toxicity
Incidence of Treatment-Related Adverse Events
时间窗: Through study completion, an average of 19 months
As measured by the incidence, nature and severity of adverse events (AEs) and serious AEs
Preliminary evaluation of AMV564 efficacy in subjects enrolled in the expansion phase
时间窗: During Dose Expansion, an average of 1 year
As measured by the objective response rate (ORR)
次要结局
- Maximum observed drug concentration (Cmax) of AMV564(Through study completion, an average of 19 months)
- Time of the maximum drug concentration (Tmax) of AMV564(Through study completion, an average of 19 months)
- Apparent terminal half-life (t½) of AMV564(Through study completion, an average of 19 months)
- Concentration at steady state (Css) of AMV564(Through study completion, an average of 19 months)
- Area under the concentration-time curve (AUC) of AMV564(Through study completion, an average of 19 months)