A First-in-Human, Open-Label, Multi-Center Phase I/II Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antitumor Activity of ALK201 for Injection in Adult Participants With Advanced Solid Tumors
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 202
- 试验地点
- 38
- 主要终点
- To evaluate the safety and tolerability of ALK201 in adult participants with advanced solid tumors; To determine the maximum tolerated dose (MTD); To determine the recommended dose(s) of ALK201 for subsequent clinical studies.
研究概览
简要总结
This is a first-in-human (FIH), open-label, multicenter dose escalation and expansion study of ALK201. The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), and antitumor activity of ALK201 as a monotherapy in adult participants with Advanced Solid Tumors. The study will also identify recommended dose(s) for subsequent clinical studies of ALK201.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women ≥18 and ≤75 years old on the day of signing the ICF
- •At least 1 measurable lesion per RECIST v1.1
- •Expected survival ≥3 months
- •Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0 or 1
- •Adequate organ function
- •Female participants of childbearing potential or male participants whose partner is a female of childbearing potential agree to use medically effective contraceptive methods from the date of signing the ICF until at least 6 months after the last dose of the IP, and during this period, male participants are not allowed to donate sperms
排除标准
- •Active or pre-existing autoimmune diseases that may relapse
- •Pleural effusion, pericardial effusion, or intraperitoneal effusion accompanied with clinical symptoms, clinically poorly controlled, or requiring repeated drainage
- •Allergies to any component of ALK201 or other monoclonal antibodies
- •Primary central nervous system malignancies, or active metastases to central nervous system and/or metastases to meninges
- •Combined with ≥ Grade 2 stomatitis and/or nose bleeding at screening
- •Vaccinated with live vaccines within 4 weeks prior to the first dose
- •Note: Other protocol defined Inclusion/Exclusion criteria may apply
研究组 & 干预措施
Part A: Dose-escalation Phase, Part B: Dose-expansion Phase
A dose-escalation study to determine the MTD and the subsequent doses for dose expansion study (Part B).
A dose-expansion study which will enroll the select indications.
干预措施: ALK201 (Drug)
结局指标
主要结局
To evaluate the safety and tolerability of ALK201 in adult participants with advanced solid tumors; To determine the maximum tolerated dose (MTD); To determine the recommended dose(s) of ALK201 for subsequent clinical studies.
时间窗: Approximately 36 months
Dose-limiting toxicity (DLT); The incidence and severity of treatment-emergent adverse events (TEAEs) and treatment-related adverse events (TRAEs) according to CTCAE v5.0.
次要结局
- To evaluate the pharmacokinetics (PK) of ALK201.(Approximately 36 months)
- To evaluate the immunogenicity of ALK201.(Approximately 36 months)
- To evaluate the biomarkers.(Approximately 36 months)
- To evaluate the pharmacokinetics (PK) of ALK201(Approximately 36 months)
- To evaluate the preliminary antitumor activity of ALK201(Approximately 36 months)