An Open Label, Multicenter, Safety and Efficacy Phase 2 Study of PRL3-Zumab in Solid Tumors
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 51
- 试验地点
- 10
- 主要终点
- Progression free survival (PFS)
研究概览
简要总结
This is a multi-center, Phase 2, open-label, single dose level study of PRL3-zumab monotherapy in patients with unresectable or metastatic solid tumor.
详细描述
The study consists of a Screening Period (Day - 14 to Day -1), a Treatment Period during which visits will occur every 2 weeks, an End of Treatment visit within 14 days of the decision to discontinue treatment for any reason, and a Safety Follow-up visit at 14 ± 4 days after the last dose of study treatment. PRL3-zumab will be administered by intravenous (IV) infusion till patient meets any of the discontinuation criteria (progressive disease, clinically or per RECIST v1.1 and iRECIST, intolerable toxicity or withdrawal of consent). One cycle of treatment will be 4 weeks (2 infusions, 12 days ±2 days apart).
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
- •Patients with unresectable or metastatic solid tumors willing to provide signed informed consent.
- •Histopathological diagnosis and metastatic status cancer at study entry.
- •Must have received at least 1 prior line of systemic therapy for metastatic disease but no more than 3 prior lines of treatment for metastatic disease.
- •Life expectancy of more than 6 months.
- •Eastern Cooperative Oncology Group (ECOG) performance status (PS) score or less than
- •Adequate organ and hematological function.
- •Measurable disease by RECIST v1.1 and iRECIST.
排除标准
- •Patient has known untreated or symptomatic central nervous system metastasis.
- •Patient is receiving systemic glucocorticoids or other immunosuppressive treatments for autoimmune disease or any other medical condition.
- •Patient has experienced a severe hypersensitivity reaction to another monoclonal antibody.
- •Patient has received treatment with any systemic anti-cancer therapies within 3 weeks prior to starting study treatment.
- •Patient has undergone radiotherapy ≤ 4 weeks prior to starting study treatment.
- •Patient has received > 3 lines of prior systemic chemotherapy for metastatic disease
研究组 & 干预措施
PRL3-zumab
All patients will receive PRL3-zumab until clinical progression per RECIST v1.1 and iRECIST criteria, or unacceptable toxicity, or withdraws consent.
干预措施: PRL3-zumab (Biological)
结局指标
主要结局
Progression free survival (PFS)
时间窗: From first dose of study drug until disease progression or end of treatment, whichever comes first
PFS is defined as the time from the initiation of study treatment to the date of disease progression as per RECIST v1.1 and iRECIST criteria.
次要结局
- Objective Response Rate (ORR)(Time Frame: From first dose of study drug until disease progression or end of treatment, whichever comes first.)
- Clinical benefit rate (CBR)(Time Frame: From first dose of study drug until disease progression or end of treatment, whichever comes first)
- Overall survival (OS)(Time Frame: From first dose of study drug until disease progression or end of treatment, whichever comes first)
- Duration of response(Time Frame: From first dose of study drug until disease progression or end of treatment, whichever comes first)
- Terminal elimination half life (t½)(Pre-dose and during first dose of C1, pre dose C1D15, C2D1, C2D15, C3D1, and pre dose and during the second dose of C3, pre-dose C4D1, C5D1, C6D1 and at end of treatment (up to approximately 6 months). Duration of 1 cycle is 4 weeks. C = Cycle, D = Day.)
- Maximum plasma PRL3-zumab concentration (Cmax)(Pre-dose and during first dose of C1, pre dose C1D15, C2D1, C2D15, C3D1, and pre dose and during the second dose of C3, pre-dose C4D1, C5D1, C6D1 and at end of treatment (up to approximately 6 months). Duration of 1 cycle is 4 weeks. C = Cycle, D = Day.)
- Time of Cmax (tmax)(Pre-dose and during first dose of C1, pre dose C1D15, C2D1, C2D15, C3D1, and pre dose and during the second dose of C3, pre-dose C4D1, C5D1, C6D1 and at end of treatment (up to approximately 6 months). Duration of 1 cycle is 4 weeks. C = Cycle, D = Day.)
- Area under the concentration time curve from pre-dose (AUCinf)(Pre-dose and during first dose of C1, pre dose C1D15, C2D1, C2D15, C3D1, and pre dose and during the second dose of C3, pre-dose C4D1, C5D1, C6D1 and at end of treatment (up to approximately 6 months). Duration of 1 cycle is 4 weeks. C = Cycle, D = Day.)
- Number of patients with adverse events and serious adverse events(From first dose of study drug until disease progression or end of treatment, whichever comes first)
- European Quality-5D (EQ-5D)(From first dose of study drug until disease progression or end of treatment, whichever comes first)
- European Organization for Research and Treatment of Cancer-quality of life quantionnaire-C30 (EORTC-QLQ-C30)(From first dose of study drug until disease progression or end of treatment, whichever comes first)