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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT03736122




Registration number
NCT03736122
Ethics application status
Date submitted
30/10/2018
Date registered
8/11/2018
Date last updated
8/11/2018

Titles & IDs
Public title
A Study of Syngenon (BSG-001) for Inhalation in Subjects With Malignant Pleural Effusion and/or Malignant Ascites
Scientific title
A Phase I/IIa Study of Syngenon (BSG-001) for Inhalation in Subjects With Malignant Pleural Effusion and/or Malignant Ascites
Secondary ID [1] 0 0
BSG-001-001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Malignant Pleural Effusion 0 0
Malignant Ascites 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Other respiratory disorders / diseases
Cancer 0 0 0 0
Other cancer types
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - BSG-001

Experimental: BSG-001 - Inhalation route, daily


Treatment: Drugs: 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).

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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
Timepoint [1] 0 0
From start of treatment throughout 12 weeks dosing
Primary outcome [2] 0 0
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)
Timepoint [2] 0 0
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 outcome [1] 0 0
Recommended dose (RD) of BSG-001 - RD will be assessed with incidence of BSG-001-related Adverse Events Grading during the dose limiting toxicity (DLT) period
Timepoint [1] 0 0
Start of treatment throughout 28-day DLT dosing period

Eligibility
Key inclusion criteria
1. 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

2. Histologically confirmed cancer

3. Malignant pleural effusion and/or malignant ascites clinically judged as not
responsive to conventional systemic therapy(ies) for primary malignancy

4. Adequate liver and renal function as defined below:

5. Eastern Cooperative Oncology Group (ECOG) performance status = 2

6. Life expectancy of > 12 weeks

7. 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

8. 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.

9. Willing and able to comply with all study procedures
Minimum age
21 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Presence of > grade 3 active infection or gastric bleeding at the time of screening

2. Change in chemotherapy regimen within 28 days before Day 1 of study drug
administration

3. Concurrent use of any investigational product (IP) or investigational medicine within
28 days before Day 1 of study drug administration

4. Symptomatic interstitial lung disease or inflammatory pneumonitis

5. 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

6. Breastfeeding at screening or planning to become pregnant (self or partner) at any
time during study participation

Study design
Purpose of the study
Treatment
Allocation to intervention
N/A
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 1/Phase 2
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 0 0
Flinders Medical Centre - Adelaide
Recruitment postcode(s) [1] 0 0
5042 - Adelaide

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
BioSyngen Pte Ltd
Address
Country

Ethics approval
Ethics application status

Summary
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).
Trial website
https://clinicaltrials.gov/show/NCT03736122
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Lietao Li, MD
Address 0 0
BioSyngen Australia Pty Ltd
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Grace Khoo Koay
Address 0 0
Country 0 0
Phone 0 0
(65) 6926 0818
Fax 0 0
Email 0 0
clinicaltrials@biosg.com
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT03736122