A First-in-Human (FIH), Open-Label, Phase 1 Study of ADG206, a CD137 Agonist Antibody, in Subjects With Advanced/Metastatic Solid Tumors
概览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- Adagene Inc
- 入组人数
- 14
- 试验地点
- 2
- 主要终点
- Maximum tolerated dose (MTD) of ADG 206
概览
简要总结
ADG206 is an activatable prodrug form of a fully human monoclonal antibody (mAb) of the immunoglobulin G1 (IgG1) subclass that specifically targets cluster of differentiation 137 (CD137) (also known as 4-1BB) as a co-stimulatory receptor agonist for the treatment of advanced malignancies.
详细描述
This is a FIH, Phase 1, open-label, multicenter, sequential dose escalation study to evaluate the safety, tolerability, Pharmacokinetics (PK), and preliminary efficacy of ADG206 in subjects with advanced/metastatic malignancies.
Primary Objective of the study: To assess safety and tolerability at increasing dose levels of ADG206 in subjects with advanced/metastatic solid tumors who have exhausted their treatment alternatives.
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
- •Eastern Cooperative Oncology Group (ECOG) performance status ≤
- •Subjects with advanced or metastatic solid tumors (except thymic tumors), which have progressed after all standard therapies, or no further standard therapies exists.
- •At least 1 measurable lesion per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1).
- •Adequate organ function.
- •Woman of childbearing potential must agree to use 2 methods of acceptable contraception from screening until 6 months after the last dose of study drug.
- •Male subjects who are sexually active with a female partner of childbearing potential must agree to use a barrier contraception.
排除标准
- •Subjects within washout period of other anti-tumor therapies. .
- •History of prior malignancy other than the cancer under treatment in the study.
- •Major trauma or major surgery within 4 weeks before the first dose of study drug.
- •Serious nonhealing wound, ulcer, or bone fracture.
- •History of significant immune-mediated AE.
- •Central nervous system (CNS) disease involvement.
- •Any evidence of underlying severe liver dysfunction.
- •Prior organ allograft transplantations or allogeneic bone marrow, cord blood or peripheral blood stem cell transplantation.
- •Clinically significant cardiac disease with insufficient cardiac function.
- •Evidence of active uncontrolled viral, bacterial, or systemic fungal infection.
研究组 & 干预措施
ADG206 dose escalation
干预措施: ADG206 (Drug)
结局指标
主要结局
Maximum tolerated dose (MTD) of ADG 206
时间窗: At the end of the last dose (each cycle is 21 days)
Number of participants experiencing dose-limiting toxicities escalating dose levels
时间窗: At the end of Cycle 1 (each cycle is 21 days)
Recommended Phase 2 dose (RP2D) of ADG206
时间窗: At the end of the last dose (each cycle is 21 days)
Number of participants with adverse events (AE)
时间窗: At the end of 90 days post last dose (each cycle is 21 days)
Maximum administered dose (MAD) of ADG206
时间窗: At the end of the last dose (each cycle is 21 days)
次要结局
- Maximum concentration (Cmax)(At the end of the last dose (each cycle is 21 days))
- Time to maximum plasma concentration (Tmax)(At the end of the last dose (each cycle is 21 days))
- The area under the curve (AUC) of plasma concentration of drug(At the end of the last dose (each cycle is 21 days))
- Immunogenicity endpoints include antidrug antibodies (ADAs)(At the end of the last dose (each cycle is 21 days))
- Lowest plasma concentration (C[trough])(At the end of the last dose (each cycle is 21 days))