Phase I/II Clinical Trial of 6MW3211 Injection to Evaluate Safety, Tolerability, PK/PD, Immunogenicity and Preliminary Efficacy in Subjects With Advanced Malignant Neoplasm.(Only Phase I Has Been Submitted to US FDA)
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 272
- 试验地点
- 1
- 主要终点
- AEs
研究概览
简要总结
This study is a single arm, non-randomized, open label, multiple doses phase I/II international, multicenter clinical trial to evaluate safety, tolerability, PK/PD, immunogenicity and preliminary efficacy in subjects with advanced malignant neoplasm. The study is consisted of two stages: dose escalation and clinical expansion.
Only Phase I has been submitted to US FDA,and the protocol number is still the same as 6MW3211-2021-CP101.The US title is : A Phase 1, First-in-Human (FIH), Multicenter, Open-Label, Dose Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of 6MW3211 in Patients with Advanced Malignancies .
详细描述
Six cohorts are included in dose escalation stage, at doses of 0.3~45 mg/kg, respectively. Safety, tolerability, and dose-limiting toxicity (DLT) are assessed during the first 3 weeks (21 days) after initial administration. Then, the intended dosing frequency is every 2 weeks (Q2W), IV.
From the first study drug administration, some dosing cycles will be observed for phase I, initial tumor efficacy assessments will be performed at week 7, after that tumor efficacy assessment will be carry out for every 6 weeks.
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
- •Men or women, age ≥
- •2.Subjects with advanced malignancy histopathologically and/or cytologically, with at least one evaluable tumor lesion.
- •3.ECOG PS is 0 or
- •4.Survival expectation of at least 3 months.
- •5.Adequate organs and hematopoietic functions
- •6.Voluntarily signing of informed consent
排除标准
- •1.Subjects with brain metastases of clinically active central nervous system (CNS).
- •2.Subjects that require to take anticoagulants and/or aspirin.
- •3.Blood transfusion within 2 weeks prior to the first administration of study treatment.
- •4.Inadequately controlled body cavity effusions.
- •5.Subjects with active, or have a history and possible recurrence of autoimmune diseases .
- •6.Have uncontrolled systemic diseases.
- •7.Subjects who had received anticancer therapy or radiotherapy within 4 weeks or 5 half-lives (whichever is shorter) before enrollment.
- •8.Subjects are known to have previously experienced severe allergic reactions to large molecular protein formulations/monoclonal antibodies.
- •9.Pregnant or lactating women.
研究组 & 干预措施
6MW3211
- Dosage form: injection
- Specification: 240 mg / 8 ml/Vial
干预措施: Intravenous Infusion (Drug)
结局指标
主要结局
AEs
时间窗: Up to 28 days post last dose
All the adverse events
DOR
时间窗: 1 Year
Duration of Remission
PFS
时间窗: 1 Year
Progression-Free Survival
OS
时间窗: 1 Year
Overall Survival
ORR
时间窗: 1 Year
Objective Response Rate
DCR
时间窗: 1 Year
Disease Control Rate
次要结局
- PK Parameters(1 Year)