A Phase I/II, Multicenter, Open-Label, Dose Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Pharmacodynamics of 6MW3511 in Patients With Advanced Solid Tumor
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 272
- 主要终点
- Number of participants with a Dose Limiting Toxicity (DLT)
研究概览
简要总结
This is a phase I/II , open-label, multicenter single arm study designed to evaluate the safety, tolerability, pharmacokinetic (PK), and immunogenicity of 6MW3511.
详细描述
This is a Phase I/II, open-label, dose-escalation trial with consecutive parallel-group expansion in selected solid tumor indications. The study consists of a dose escalation phase to determine the maximum tolerated dose (MTD), or recommended Phase 2 dose (RP2D) for 6MW3511, and a dose expansion phase which will characterize treatment of 6MW3511 at the RP2D.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •In dose-escalation cohorts, histologically or cytologically documented advanced or metastatic solid tumor that is refractory/relapsed to standard therapies, or for which no effective standard therapy is available, or the subject refuses standard therapy.In the dose-expansion cohorts , histologically or cytologically confirmed selected advanced solid tumors (to be determined).
- •Male or female subjects aged over 18 years old (inclusive) and not more than 80 years old (inclusive).
- •Eastern Cooperative Oncology Group (ECOG) Performance Score of 0 or 1.
排除标准
- •History of other malignant tumors within 3 years, except for the tumors that had been cured.
- •Symptomatic or active central nervous system metastasis.
- •Patients with active autoimmune disease.
- •History of allogeneic hematopoietic stem cell transplantation or organ transplantation.
- •Patients previously treated with PD-（L）1/ TGF-β antibody or combined PD-（L）1 with TGF-β antibody.
- •Pregnant or breast feeding.
研究组 & 干预措施
Experimental: 6MW3511
Subjects will receive 6MW3511 by intravenous administration.
干预措施: Intravenous Infusion (Drug)
结局指标
主要结局
Number of participants with a Dose Limiting Toxicity (DLT)
时间窗: Up to Week 3
DLTs will be assessed during the first 3 weeks of treatment for dose-escalation phase.
Number of participants with adverse events (AEs)
时间窗: Up to 4 weeks after last treatment
Characterization of incidence, severity and abnormal clinically significant laboratory findings of AEs.
次要结局
- Objective response rate (ORR)(Up to 2 years)
- Disease control rate (DCR)(Up to 2 years)
- Maximum observed concentration (Cmax) of 6MW3511(Up to 4 weeks after last treatment)
- Number of subjects who develop detectable anti-drug antibodies (ADAs)(Up to 4 weeks after last treatment)