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
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 145
- 试验地点
- 27
- 主要终点
- Confirmed objective response rate (Part 2)
研究概览
简要总结
The purpose of this study is to find out if ZW191 is safe and can treat participants with advanced cancers, including ovarian, endometrial, and non-small cell lung cancers.
详细描述
Part 1 of the study will evaluate the safety and tolerability of ZW191. Part 2 of the study will further evaluate safety and explore the potential anti-tumor activity of ZW191.
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
- •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 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.
研究组 & 干预措施
ZW191
干预措施: ZW191 (Drug)
结局指标
主要结局
Confirmed objective response rate (Part 2)
时间窗: Up to approximately 2 years
Number of participants who achieved a best overall response of either confirmed complete response (CR) or partial response (PR) during treatment according to the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
Incidence of dose-limiting toxicities (DLTs; Part 1)
时间窗: Up to 3 weeks
Number of participants who experienced a DLT. DLTs include specifically defined adverse events (AEs) considered to be related to ZW191
Incidence of adverse events (AEs; Parts 1 and 2)
时间窗: Up to approximately 2 years
Number of participants who experienced AEs, adverse events of special interest (AESIs), or serious adverse events (SAEs)
Incidence of clinical laboratory abnormalities (Parts 1 and 2)
时间窗: Up to approximately 2 years
Number of participants who experienced a maximum severity of Grade 3 or higher post-baseline laboratory abnormality, including either hematology or chemistry. Grades are defined using National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE), version 5.0
次要结局
- Clinical benefit rate (Parts 1 and 2)(Up to approximately 2 years)
- Confirmed objective response rate (Part 1)(Up to approximately 2 years)
- Best overall response (BOR; Part 2)(Up to approximately 2 years)
- Serum or plasma concentration and PK parameters of ZW191 (Parts 1 and 2)(Up to approximately 2 years)
- Incidence of anti-drug antibodies (ADAs; Parts 1 and 2)(Up to approximately 2 years)
- Disease control rate (DCR; Part 2)(Up to approximately 2 years)
- Duration of response (DOR; Part 2)(Up to approximately 2 years)
- Progression-free survival (PFS; Part 2)(Up to approximately 2 years)