A Phase I/II Study of MHB039A for Advanced Solid Tumor to Evaluate the Efficacy and Safety
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 196
- 试验地点
- 1
- 主要终点
- Incidence of participants with adverse events (AE)
研究概览
简要总结
Phase I/II open label, multicenter study to evaluate the efficacy and safety of MHB039A in advanced malignant tumors.
详细描述
This first-in-human, dose escalation and dose expansion study is to evaluate the safety, tolerability, pharmacokinetics (PK), immunogenicity, pharmacodynamics (PD) and anti-tumor activity of MHB039A in patients with advanced solid tumor. The Phase I stage （dose escalation）is to determine the maximum tolerated dose (MTD). The phase II stage （dose expansion）is to determine the recommended Phase 2 dose (RP2D) according to safety and efficacy in specific tumor types.
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
- •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.
- •Written and signed informed consent
- •Aged 18 years or older
- •Eastern Cooperative Oncology Group (ECOG) Performance Score of 0 or 1
- •Life expectancy >=3 months
排除标准
- •Prior malignancy active within the previous 5 years except for the tumor for which a subject is enrolled in the study, and locally curable cancers that have been apparently cured, (e.g. basal cell skin cancer, or carcinoma in situ of the cervix or others)
- •Receiving any chemotherapy within 3 weeks prior to the first dose；or other systemic anticancer therapy within 4 weeks prior to the first dose
- •Receiving prior anti-PD-1, anti-PD-L1, anti-CTLA(cytotoxic T-lymphocyte-associated protein)-4 or any other immunotherapy or immune-oncology (IO) agent within 28 days of first dose with MHB039A or experienced a toxicity that led to permanent discontinuation of prior immunotherapy
- •Unresolved toxicities from prior anticancer therapy
研究组 & 干预措施
MHB039A
MHB039A IV every 2 weeks or every 3 weeks (including 5mg/kg、10mg/kg、20mg/kg and 30mg/kg)
干预措施: MHB039A (Drug)
结局指标
主要结局
Incidence of participants with adverse events (AE)
时间窗: Until 30 days after last dose of MHB039A
An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product temporally associated with the use of study treatment, whether or not considered related to the study treatment.
Number of participants with dose-limiting toxicity (DLT)
时间窗: At the end of Cycle 1 (each cycle is 21 days for every three weeks cohort and 28 days for every two weeks cohort)
DLTs will be assessed during the dose-escalation phase and are defined as toxicities related to MHB039A which meet pre-defined severity criteria and occurs within the first cycle of treatment.
次要结局
- Objective response rate (ORR)(Until 30 days after last dose of MHB039A)
- The area under the plasma concentration-time curve (AUC) of MHB039A(Until 30 days after last dose of MHB039A)
- To detectable anti-drug antibodies with treated subjects(Until 30 days after last dose of MHB039A)
- Maximum Plasma Concentration (Cmax) of MHB039A(Until 30 days after last dose of MHB039A)