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A Study of Syngenon (BSG-001) for Inhalation in Subjects With Malignant Pleural Effusion and/or Malignant Ascites

NCT03736122 · Status: UNKNOWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 58

Last updated 2018-11-08

No results posted yet for this study

Summary

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).

Conditions

  • Malignant Pleural Effusion
  • Malignant Ascites

Interventions

DRUG

BSG-001

BSG-001 is in solution form, 4mg per vial (2mg/mL) with Inhalation as route of administration using nebulizer. BSG-001 will be administrated as an approximately 5 - 30 minutes inhalation session daily for 3 cycles (in repeated 28 days cycle).

Sponsors & Collaborators

  • BioSyngen Pte Ltd

    lead INDUSTRY

Principal Investigators

  • Lietao Li, MD · BioSyngen Australia Pty Ltd

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-01-31
Primary Completion
2022-01-31
Completion
2022-01-31

Countries

  • Australia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03736122 on ClinicalTrials.gov