A Multicenter, Open-label, Single-arm Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of Allogeneic WTX-212C Engineered Red Blood Cell Injection in Patients With Advanced Solid Tumors
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Incidence and Severity of Treatment-Related Adverse Events (TRAEs)
研究概览
简要总结
This is a multicenter, open-label, single-arm Phase I study to evaluate the safety, tolerability, pharmacokinetics (PK), immunogenicity, and preliminary antitumor activity of allogeneic WTX-212C, an investigational allogeneic engineered red blood cell (RBC)-based product, in patients with advanced solid tumors who have failed standard therapies or have no available standard treatment options.
The study consists of a dose-escalation phase using a 3+3 design followed by a dose-expansion phase. Participants will receive allogeneic WTX-212C via intravenous infusion. Tumor assessments will be performed every 6 weeks according to RECIST 1.1.
详细描述
This Phase I study aims to characterize the safety profile, dose-limiting toxicities (DLTs), maximum tolerated dose (MTD), pharmacokinetics, immunogenicity, and preliminary efficacy of allogeneic WTX-212C in patients with advanced solid tumors.
The dose-escalation phase will follow a traditional 3+3 design with predefined dose levels. The dose-expansion phase will further evaluate safety, PK, and antitumor activity at selected dose levels.
Exploratory analyses will include immune profiling, tumor microenvironment assessment, and evaluation of biomarkers such as PD-1/PD-L1 expression, tumor mutational burden (TMB), and microsatellite instability (MSI) status.
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
- •Age 18-75 years
- •Histologically or cytologically confirmed advanced solid tumors
- •At least one measurable lesion per RECIST 1.1
- •ECOG performance status ≤1
- •Adequate organ function
- •Life expectancy ≥12 weeks
排除标准
- •Uncontrolled serious medical conditions
- •Active or uncontrolled infections
- •Symptomatic or unstable CNS metastases
- •History of severe hypersensitivity to biologic agents
- •Autoimmune diseases requiring systemic treatment
- •Prior severe immune-related adverse events
- •Conditions affecting red blood cell integrity
研究组 & 干预措施
Experimental: Allogeneic WTX-212C
Participants will receive allogeneic WTX-212C via intravenous infusion in dose-escalation and dose-expansion cohorts.
干预措施: allogeneic WTX-212C (Drug)
结局指标
主要结局
Incidence and Severity of Treatment-Related Adverse Events (TRAEs)
时间窗: Up to 12 months
Incidence of Dose-Limiting Toxicities (DLTs)
Incidence of Dose-Limiting Toxicities (DLTs)
时间窗: Within 21 days after the first dose
Incidence of Dose-Limiting Toxicities (DLTs)
次要结局
- Maximum Tolerated Dose (MTD)(Within 21 days after the first dose)
- Pharmacokinetic Parameters (Cmax)(From first dose up to 12 months)
- Objective Response Rate (ORR)(Up to 12 months)
- Disease Control Rate (DCR)(Up to 12 months)
- Progression-Free Survival (PFS)(Up to 12 months)
- Incidence of Anti-Drug Antibodies (ADA)(From baseline up to 12 months)
- Pharmacokinetic Parameters (AUC)(From first dose up to 12 months)
- Pharmacokinetic Parameters (Tmax)(From first dose up to 12 months)
- Pharmacokinetic Parameters (T1/2)(From first dose up to 12 months)
研究者
Liu Yang
Principal Investigator
Zhejiang Provincial People's Hospital