An Open Label, Multicenter, Safety and Efficacy Phase II/III Study of PRL3-Zumab in Solid Tumor Patients
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 52
- 试验地点
- 4
- 主要终点
- Progression free survival (PFS)
研究概览
简要总结
This is a Multi-Center, Phase II/III, open-label, single dose level (6 mg/kg) basket trial of PRL3-zumab monotherapy in solid cancer patients.
The study will consist of a Screening Period (Day - 14 to Day -1) for completion of all screening assessments before the first administration of study treatment, a Treatment Period during which visits will occur every 2-week (PK T1/2 = 12 days ±2 days), once the decision to discontinue treatment for any reason, an End of Treatment (EOT) visit will be performed within 14 days ±4 days after last dose of study treatment. Safety Follow-up/EOS visit will be performed 28 days ±2 days after last dose of study treatment and survival follow-up call will be performed every month up to 6 months after EOS visit.
PRL3-zumab will be administered by intravenous (i.v.) infusion till patient meets discontinuation criteria (progressive disease, clinically or per iRECIST, intolerable toxicity or withdrawal of consent). One cycle of treatment will be 4-weeks (2 infusions, 12 days±2 days apart). Patients will undergo safety assessment including laboratory tests prior to each infusion. Efficacy will be assessed by iRECIST at baseline and every 4 doses after study treatment. QoL assessments will be performed at Screening and every 4 doses ±7 days during treatment. A patient will be discontinued from study treatment if the patient progress clinically or per iRECIST criteria, or for intolerable toxicity, or if the patient withdraws consent. An EOT visit will be performed within14 days ±4 days after last study treatment dose.
详细描述
Safety:
Patient safety will be evaluated based on physical examination, vital signs (blood pressure [systolic and diastolic], heart rate, respiratory rate, and temperature), clinical laboratory tests (hematology, clinical chemistry, coagulation) and adverse events per CTCAE v5. Patient safety will be assessed on an ongoing basis during each cycle.
Quality of life assessment EQ-5D and EORTC-QLQ-C30 questionnaire scores will be obtained at Screening and every 2 cycles (8 weeks ± 2 days) for C1 to C4 and 8 weeks ±7 days for the rest of the scheduled visits) for the duration of the study.
DURATION OF THE STUDY:
The planned duration of the treatment is till patient meets discontinuation criteria. In addition, the study includes a patient enrolment period of 14 days, EOT visit within 14 days after last dose of study treatment and an EOS visit for safety follow-up 28 days after the last dose of study treatment. Survival study follow-up call will be done monthly till 6 months after EOS visit.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women aged 18 - 75 years with solid tumors
- •Willing to provide written informed consent for the study.
- •Histopathological diagnosis and metastatic status cancer at study entry.
- •Stage 1-3 patients with no more than 3 prior lines of treatment
- •Life expectancy of more than 6 months (especially for Pancreatic cancer patients).
- •Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0 or
- •Patient should have recovered from toxicity of prior treatment regimen to Grade 1 level except for alopecia or peripheral neuropathy or fatigue as defined by Common Terminology Criteria for Adverse Events (CTCAE) version
- •Women of childbearing potential (WOCBP) must have a negative serum pregnancy test at study entry and must follow highly effective contraception
- •Adequate organ and hematological function as evidenced by the following laboratory studies within 10 days of treatment:
- •Absolute neutrophil count ≥ 1.0 x 109/L.
- •Platelet count ≥ 75 x 109/L. Hemoglobin ≥ 90 g/L (9 g/dL).
- •Prothrombin time and activated partial thromboplastin time ≤ 1.5 x upper limit of normal (ULN) per institutional laboratory normal range.
- •Total bilirubin ≤ 1.5x ULN.
- •Aspartate aminotransferase and alanine aminotransferase ≤ 2.5 x upper limit of normal (ULN) (≤ 5 x ULN in the presence of liver metastases).
- •For patients with hepatocellular carcinoma (HCC) Child Pugh score of ≤ B
- •Creatinine < 1.5x ULN.
- •Measurable disease by iRECIST.
- •No history of active hepatitis B or C infection.
排除标准
- •Patient has known untreated or symptomatic central nervous system metastasis.
- •Female patient is pregnant, breastfeeding, or expecting to conceive children while receiving study treatment and for 150 days (for pregnancy or conception) or 30 days (for breastfeeding) after the last dose of study treatment.
- •Patient has known history of human immunodeficiency virus (HIV) infection (HIV-1 or HIV-2 antibodies).
- •Patient is receiving systemic glucocorticoids (only if higher than 10 mg or equivalent of prednisolone daily) or other immunosuppressive treatment 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 or limited field radiation for palliation ≤ 2 weeks prior to starting study treatment.
- •Patient is unable to provide informed consent.
- •Patient has received a prior stem cell or bone marrow transplant.
- •Patient with abnormal cachexia.
- •Patient with distended abdomen from ascites.
- •Patient is currently participating in a treatment study or has participated in a study of an investigational agent within 4 weeks prior to the anticipated first dose of study treatment in this study.
研究组 & 干预措施
Experimental: PRL3-ZUMAB Monotherapy
Single Arm
干预措施: PRL3-ZUMAB (Biological)
结局指标
主要结局
Progression free survival (PFS)
时间窗: Time Frame: From the date of first dose of study drug until first documented disease progression or date of death from any cause, whichever comes first, assessed up to 12 months.
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.
Time to Progression (TTP)
时间窗: From the date of first dose of study drug until first documented disease progression, assessed up to 12 months.
TTP is defined as the time from the the initiation of study treatment to the date of disease progression as per RECIST v1.1 and iRECIST criteria which does not include deaths.
Progression free survival (PFS)
时间窗: Time Frame: From the date of first dose of study drug until first documented disease progression or date of death from any cause, whichever comes first, assessed up to 12 months.
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.
Time to Progression (TTP)
时间窗: From the date of first dose of study drug until first documented disease progression, assessed up to 12 months.
TTP is defined as the time from the the initiation of study treatment to the date of disease progression as per RECIST v1.1 and iRECIST criteria which does not include deaths.
次要结局
- Clinical benefit rate (CBR)(Time Frame: From date of first dose of study drug until first documented disease progression or date of death, whichever comes first, assessed at every 8 weeks up to 48 weeks.)