A Phase 1, Open-label, Multicenter Study of ZW171 in Participants With Advanced or Metastatic Ovarian Cancer, Non-small Cell Lung Cancer (NSCLC), and Other Mesothelin Expressing Cancers
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 32
- 试验地点
- 15
- 主要终点
- Incidence of adverse events (AEs; Parts 1 and 2)
研究概览
简要总结
This study is being done to find out if ZW171 is safe and can treat participants with advanced (locally advanced [inoperable] and/or metastatic) mesothelin-expressing cancers.
详细描述
Part 1 of the study will evaluate the safety and tolerability of ZW171. Part 2 of the study will evaluate the anti-tumor activity of ZW171 while continuing to evaluate the safety and tolerability.
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 confirmed diagnosis of cancers with evidence of locally advanced (unresectable) and/or metastatic disease. Cancers that are refractory to all available standard of care (SOC) treatment, cancers for which no SOC treatment is available, or the participant cannot tolerate or refuses SOC therapy.
- •An Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or
- •Adequate cardiac left ventricular function, as defined by left ventricular ejection fraction ≥ 50% as determined by either echocardiogram or multigated acquisition scan.
- •Adequate organ function.
排除标准
- •Known additional malignancy that is progressing or that has required active treatment.
- •Undergone prior allogenic tissue (e.g., hematopoietic stem cell) or solid organ transplantation within the last 5 years.
- •Ongoing, clinically significant toxicity (Grade ≥ 2) associated with prior cancer therapies, with the exception of alopecia.
- •Advanced/metastatic, symptomatic, visceral spread, at risk of life-threatening complications in the short-term (including participants with massive uncontrolled effusion [pleural, pericardial], pulmonary lymphangitis, active unresolved bowel obstruction, massive ascites [requiring paracentesis >2 times within 2 weeks prior to the first dose], and over 50% liver involvement).
- •Acute or chronic uncontrolled renal disease, pancreatitis, or liver disease (with exception of participants with Gilbert's Syndrome, asymptomatic gall stones, liver metastases, or stable chronic liver disease per investigator assessment).
- •Active or recurrent clinically significant autoimmune disease requiring systemic high-dose corticosteroids or immunosuppressive drugs.
研究组 & 干预措施
ZW171
干预措施: ZW171 (Drug)
结局指标
主要结局
Incidence of adverse events (AEs; Parts 1 and 2)
时间窗: Up to approximately 2 years
Number of participants who experienced AEs or serious adverse events (SAEs)
Incidence of neurotoxicity, including immune effector cell-associated neurotoxicity syndrome (ICANS; Parts 1 and 2)
时间窗: Up to approximately 2 years
Number of participants who experienced neurotoxicity, including ICANS
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
Incidence of cytokine release syndrome (CRS; Parts 1 and 2)
时间窗: Up to approximately 2 years
Number of participants who experienced CRS
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 ZW171
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
次要结局
- Overall survival (OS), including 1-year OS (Part 2)(Up to approximately 2 years)
- Incidence of anti-drug antibodies (ADAs; Parts 1 and 2)(Up to approximately 7 months)
- Duration of response (DOR; Part 2)(Up to approximately 2 years)
- Progression-free survival (PFS), including 1-year PFS (Part 2)(Up to approximately 2 years)
- Confirmed objective response rate (Part 1)(Up to approximately 2 years)
- Disease control rate (DCR; Part 2)(Up to approximately 2 years)
- Serum concentration of ZW171 (Parts 1 and 2)(Up to approximately 7 months)