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

Primary Purpose

Malignant Pleural Effusion, Malignant Ascites

Status

Unknown status

Phase

Phase 1

Locations

Australia

Study Type

Interventional

Intervention

BSG-001

About this trial

This is an interventional treatment trial for Malignant Pleural Effusion

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

Flinders Medical Centre

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

BSG-001

Arm Description

Inhalation route, daily

Outcomes

Primary Outcome Measures

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

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)

Secondary Outcome Measures

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

Full Information

NCT ID

NCT03736122

First Posted

October 30, 2018

Last Updated

November 7, 2018

Sponsor

BioSyngen Pte Ltd

1. Study Identification

Unique Protocol Identification Number

NCT03736122

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2018

Overall Recruitment Status

Unknown status

Study Start Date

January 2019 (Anticipated)

Primary Completion Date

January 2022 (Anticipated)

Study Completion Date

January 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

BioSyngen Pte Ltd

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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).

Detailed Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Malignant Pleural Effusion, Malignant Ascites

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

58 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

BSG-001

Arm Type

Experimental

Arm Description

Inhalation route, daily

Intervention Type

Drug

Intervention Name(s)

BSG-001

Intervention Description

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).

Primary Outcome Measure Information:

Title

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

Description

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

Time Frame

From start of treatment throughout 12 weeks dosing

Title

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

Description

Time Frame

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 Measure Information:

Title

Recommended dose (RD) of BSG-001

Description

RD will be assessed with incidence of BSG-001-related Adverse Events Grading during the dose limiting toxicity (DLT) period

Time Frame

Start of treatment throughout 28-day DLT dosing period

Other Pre-specified Outcome Measures:

Title

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

Description

Reported quality of life will be assessed through EORTC QLQ-30 questionnaire score change from baseline, by a four-point scale (first 28 questions) and a 7-point scale (last 2 questions) total of 30 questions, where higher score represents higher (better) response level. Calculation is based on linear transformation to standardise the raw score, so that scores range from 0 to 100.

Time Frame

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

21 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Exclusion Criteria: 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Grace Khoo Koay

Phone

(65) 6926 0818

clinicaltrials@biosg.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Lietao Li, MD

Organizational Affiliation

BioSyngen Australia Pty Ltd

Official's Role

Study Director

Facility Information:

Facility Name

Flinders Medical Centre

City

Adelaide

State/Province

South Australia

ZIP/Postal Code

5042

Country

Australia

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Kathrina Bartolay

Phone

+61 8 8404 2201

Kathrina.Bartolay@sa.gov.au

First Name & Middle Initial & Last Name & Degree

Anand Rose, MD

12. IPD Sharing Statement

Learn more about this trial

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

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