jRCT2031240343招募中不适用
A Phase 1, Open-label, Multicenter Study to Assess the Safety, Tolerability, Pharmacokinetics, and Preliminary Anti-tumor Activity of Ascending Doses of a Folate Receptor Alpha Antibody Drug Conjugate, ZW191, in Participants with Advanced Solid Tumors
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 20
- 主要终点
- Incidence of dose-limiting toxicities (DLTs)
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Single Arm Study
- 干预模型
- Single Assignment
- 主要目的
- Treatment Purpose
- 盲法
- Open(masking Not Used)
入排标准
- 年龄范围
- 18age old over 至 No limit（—）
- 性别
- All
入选标准
- •Pathologically or cytologically confirmed diagnosis of cancers with evidence of locally advanced (unresectable), recurrent and/or metastatic disease.
- •Measurable disease per RECIST v1.
- •Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or
- •Adequate cardiac function: Cardiac left ventricular function, as defined by left ventricular ejection fraction (LVEF) >= 50% as determined by either echocardiogram (ECHO) or multigated acquisition scan (MUGA).
- •Other adequate organ function.
排除标准
- •Known additional malignancy that is progressing or requires active treatment or may interfere with study endpoints.
- •Has received prior Topoisomerase I inhibitor (TOPO1i) antibody drug conjugate (ADC) treatment, regardless of washout period.
- •Acute or chronic uncontrolled renal disease, pancreatitis, or liver disease.
- •Severe chronic or active infections (including known active SARS-CoV-2 infection) requiring systemic therapy, including antibacterial, antifungal, or antiviral therapy.
结局指标
主要结局
Incidence of dose-limiting toxicities (DLTs)
Part 1
Incidence of adverse events (AEs)
Parts 1 and 2
Incidence of clinical laboratory abnormalities
Parts 1 and 2
Confirmed objective response rate (cORR)
Part 2
次要结局
未报告次要终点
研究者
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