Malignant Pleural Effusion Clinical Trial
Official title:
A Phase I/IIa Study of Syngenon (BSG-001) for Inhalation in Subjects With Malignant Pleural Effusion and/or Malignant Ascites
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).
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.
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