A First-In-Human, Single-Arm, Multi-Center, Open-Label, Repeated-Dose, Dose-Escalation Study of MP0310 in Patients With Advanced Solid Tumors
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 38
- 试验地点
- 3
- 主要终点
- Maximum tolerated dose (MTD) or a tolerated dose below MTD (if MTD is not reached)
研究概览
简要总结
To evaluate the safety and tolerability of MP0310, a DARPin® therapeutic candidate for tumor targeted activation of T cells, in patients with advanced solid tumors
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
MP0310 Part B
weekly schedule, at least 3 and up to 24 patients evaluable for DLT assessment will be enrolled (1 to 4 cohorts with 3 to 6 patients each (3 initial plus up to 3 backfill patients)).
干预措施: MP0310 (Drug)
MP0310 Part C
q3w schedule implementing B-cell depletion, at least 3 and up to 12 patients evaluable for DLT assessment will be enrolled (1 to 2 cohorts with 3 to 6 patients each (3 initial plus up to 3 backfill patients)).
干预措施: MP0310 (Drug)
MP0310 Part A
Enrollment will follow a standard 3 + 3 dose escalation design. Sequential Cohorts of patients will be dosed until the MTD or unacceptable toxicity is reached. Up to 12 additional patients in total may be included at selected dose levels (up to 3).
干预措施: MP0310 (Drug)
结局指标
主要结局
Maximum tolerated dose (MTD) or a tolerated dose below MTD (if MTD is not reached)
时间窗: From signing of ICF until 10 weeks following the last dose or start of new anticancer therapy.
Based on occurrence of DLTs within a 3+3 clinical trial design
Recommended expansion dose (RED)
时间窗: From signing of ICF until 10 weeks following the last dose or start of new anticancer therapy.
Based on incidence and nature of DLTs, and incidence, nature, and severity of AEs and serious adverse events (SAEs)
Incidence of Adverse Events (AEs)
时间窗: From signing of informed consent form (ICF) until 10 weeks following the last dose or start of new anticancer therapy.
According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0
Incidence of dose-limiting toxicities (DLTs)
时间窗: First 21 days of dosing.
Dose-limiting toxicities will be reviewed as a subset of AEs that occur within the first 21 days of dosing and meet the protocol-specified criteria.
次要结局
- Total clearance (CL)(24 months)
- Serum concentration - time profiles(24 months)
- Area under the serum concentration-time curve (AUC)(24 months)
- Terminal elimination half-life (t1/2)(24 months)
- Accumulation ratio(24 months)
- Incidence of anti-drug-antibodies(24 months)
- Objective response rate (ORR)(24 months)
- Disease control rate (DCR)(24 months)
- Duration of response (DoR)(24 months)
- Volume of distribution (Vd), volume at steady state (Vss)(24 months)