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

NCT03736122 | Unknown Phase 1

• 1 other identifier: BSG-001-001
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (2)

• Safety and Tolerability of BSG-001 assessed with incidence of Treatment-Emergent Adverse Events (AEs) and Serious AEs

  Treatment-Emergent Adverse Events (AEs) and Serious AEs will be assessed by CTCAE v4.0 or higher version

  From start of treatment throughout 12 weeks dosing

• Efficacy of BSG-001 assessed with change in fluid volume of Malignant Pleural Effusion and/or Malignant Ascites

  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)

  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.

Secondary Outcomes (1)

• Recommended dose (RD) of BSG-001

  Start of treatment throughout 28-day DLT dosing period

Other Outcomes (1)

• Subjects' reported quality of life [European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTCQLQ-30), version 3]

  From screening/ baseline, followed by Day 1 of every cycle prior to other procedures (each cycle is 28 days) for 3 cycles.

Study Arms (1)

BSG-001

EXPERIMENTAL

Inhalation route, daily

Drug: BSG-001

Interventions

BSG-001 DRUG

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).

BSG-001

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• BioSyngen Pte Ltd: lead

Study Sites (1)

Flinders Medical Centre

Adelaide, South Australia, 5042, Australia

Location

MeSH Terms

Conditions

Pleural Effusion, Malignant

Condition Hierarchy (Ancestors)

Pleural Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Pleural Effusion; Pleural Diseases; Respiratory Tract Diseases

Study Officials

• Lietao Li, MD

  BioSyngen Australia Pty Ltd

  STUDY DIRECTOR

Central Study Contacts

Grace Khoo Koay

CONTACT

(65) 6926 0818; clinicaltrials@biosg.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 30, 2018
• First Posted: November 8, 2018
• Study Start: January 1, 2019
• Primary Completion: January 1, 2022
• Study Completion: January 1, 2022
• Last Updated: November 8, 2018

Record last verified: 2018-10

Locations

AU (1)