Clinical trial · Interventional
A Study of Syngenon (BSG-001) for Inhalation in Subjects With Malignant Pleural Effusion and/or Malignant Ascites
A Phase I/IIa Study of Syngenon (BSG-001) for Inhalation in Subjects With Malignant Pleural Effusion and/or Malignant Ascites
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Malignant Ascites | — | UNRESOLVED | — |
| Malignant Pleural Effusion | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| BSG-001 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- BSG-001
- description
- Inhalation route, daily
- interventionNames
- Drug: BSG-001
Primary outcomes (2)
- measure
- Safety and Tolerability of BSG-001 assessed with incidence of Treatment-Emergent Adverse Events (AEs) and Serious AEs
- timeFrame
- From start of treatment throughout 12 weeks dosing
- description
- Treatment-Emergent Adverse Events (AEs) and Serious AEs will be assessed by CTCAE v4.0 or higher version
- measure
- Efficacy of BSG-001 assessed with change in fluid volume of Malignant Pleural Effusion and/or Malignant Ascites
- timeFrame
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 21 Years
Show eligibility criteria text
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 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
References
Publications (0)
Data not yet available