A Phase I/IIa Study of Syngenon (BSG-001) for Inhalation in Subjects With Malignant Pleural Effusion and/or Malignant Ascites
试验速览
- 阶段
- 1 期
- 入组人数
- 58
- 试验地点
- 1
- 主要终点
- Safety and Tolerability of BSG-001 assessed with incidence of Treatment-Emergent Adverse Events (AEs) and Serious AEs
研究概览
简要总结
Malignant pleural effusion and/ or malignant ascites is generally defined by presence of malignant cells in the effusion fluid. The first-line therapies are mostly intrusive, medically demanding and inefficient, and therefore, it is important to study and develop new therapeutic option to address the unmet need.
This protocol for BSG-001 is developed for the treatment of malignant pleural effusion and/ or malignant ascites. BSG-001 is an immune-modulator primarily exerts its effect via Toll-like receptor.
The purpose of this study is to assess the safety and tolerability of BSG-001. All eligible subjects will receive BSG-001 for at least 12 weeks (3 cycles).
详细描述
This study is a phase 1/2a, single arm study with main purpose to evaluate the safety, tolerability and efficacy of BSG-001 in subjects with cancer that causes an abnormal amount of fluid to collect between the thin layers of tissue (pleura) lining the outside of the lung and the wall of the chest cavity, namely malignant pleural effusion and/ or subjects with cancer that causes the accumulation of fluid in the peritoneal cavity, causing abdominal swelling, namely malignant ascites.
The study aims to recruit 9 - 18 subjects in phase 1, and once the safety, tolerability and the preliminary efficacy of BSG-001 reach an optimal target exposure for recommended dose (RD), phase 2a will be opened for enrolment of approximately 40 subjects.
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
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically or cytologically documented malignant pleural effusion and/or malignant ascites OR morphological diagnosis of malignant pleural effusion and/or malignant ascites by CT or ultrasound
- •Histologically confirmed cancer
- •Malignant pleural effusion and/or malignant ascites clinically judged as not responsive to conventional systemic therapy(ies) for primary malignancy
- •Adequate liver and renal function as defined below:
- •Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
- •Life expectancy of > 12 weeks
- •Willing and able to provide written, signed informed consent after the nature of the study has been explained, and prior to any research-related procedures
- •Females of childbearing potential must have a negative serum pregnancy test at screening and be willing to have additional serum pregnancy tests during the study.
- •Willing and able to comply with all study procedures
排除标准
- •Presence of > grade 3 active infection or gastric bleeding at the time of screening
- •Change in chemotherapy regimen within 28 days before Day 1 of study drug administration
- •Concurrent use of any investigational product (IP) or investigational medicine within 28 days before Day 1 of study drug administration
- •Symptomatic interstitial lung disease or inflammatory pneumonitis
- •Concurrent disease or condition which, in the opinion of the Investigator, would pose a risk to patient safety or interfere with study participation or interpretation of individual patient results
- •Breastfeeding at screening or planning to become pregnant (self or partner) at any time during study participation
研究组 & 干预措施
BSG-001
Inhalation route, daily
干预措施: BSG-001 (Drug)
结局指标
主要结局
Safety and Tolerability of BSG-001 assessed with incidence of Treatment-Emergent Adverse Events (AEs) and Serious AEs
时间窗: From start of treatment throughout 12 weeks dosing
Treatment-Emergent Adverse Events (AEs) and Serious AEs will be assessed by CTCAE v4.0 or higher version
Efficacy of BSG-001 assessed with change in fluid volume of Malignant Pleural Effusion and/or Malignant Ascites
时间窗: From start of treatment throughout 12 weeks dosing, until disease progression and onward survival follow up up to 6 months or study completion, whichever came first.
Efficacy of BSG-001 will be assessed with change in frequency and total change volume (for subjects require paracentesis and/or thoracentesis) and assessed by radiographic imaging (CT/ ultrasound) (for subjects without catheter drainage)
次要结局
- Recommended dose (RD) of BSG-001(Start of treatment throughout 28-day DLT dosing period)