Trials / Unknown
UnknownNCT05278975
Study of RSO-021 in Patients With Malignant Pleural Effusion Due to Advanced/Metastatic Solid Tumors Including Mesothelioma
A Translational Phase 1/2 Dose-Escalation and Expansion Study to Determine Safety, Tolerability, and Recommended Phase 2 Dose of RSO-021 in Patients With Malignant Pleural Effusion Due to Advanced/Metastatic Solid Tumors Including Mesothelioma
- Status
- Unknown
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 186 (estimated)
- Sponsor
- RS Oncology LLC · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This is an open-label, non-randomized, multicenter, translational Phase 1/2 dose-escalation and expansion study designed to determine the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary anti-tumor activity of RSO-021 after intrapleural (IP) administration in patients with malignant pleural effusion (MPE) (non-mesothelioma) and MPE from mesothelioma.
Detailed description
This is a Phase 1/2, open-label, multi-center study whose primary Phase 1 stage objective is to determine the maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D) of RSO-021 (thiostrepton), a naturally-occurring, sulfur-rich, cyclic oligopeptide antibiotic of the thiopeptide class, in patients with MPE from any solid tumor, including mesothelioma. In the Phase 2 stage, once the RP2D has been identified, the antitumor activity of RSO-021 will be evaluated in four recruitment arms; (1) in patients with MPE (non-mesothelioma), (2) in patients with MPE (non-mesothelioma) in combination with paclitaxel, (3) in patients with MPE from mesothelioma after first-line SoC, and (4) in patients with MPE from mesothelioma who have a 'window of opportunity' for treatment prior to first-line systemic therapy.
Conditions
- Malignant Pleural Effusion
- Malignant Pleural Mesothelioma
- Mesothelioma
- Mesotheliomas Pleural
- Mesothelioma; Lung
- Pleural Effusion, Malignant
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | RSO-021 | A naturally-occurring, sulfur-rich, cyclic oligopeptide antibiotic of the thiopeptide class. |
Timeline
- Start date
- 2022-03-31
- Primary completion
- 2025-04-01
- Completion
- 2025-04-01
- First posted
- 2022-03-15
- Last updated
- 2024-01-26
Locations
10 sites across 1 country: United Kingdom
Source: ClinicalTrials.gov record NCT05278975. Inclusion in this directory is not an endorsement.