RS Oncology - RS-TS-101-01
Research type
Research Study
Full title
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
IRAS ID
1003789
Contact name
Neil Edwards
Contact email
Sponsor organisation
RS Oncology LLC
Eudract number
2020-003347-28
Clinicaltrials.gov Identifier
Research summary
Malignant pleural effusion (MPE) is a condition whereby excess fluid accumulates in the pleural cavity, caused by direct pleural tumor invasion, resulting in increased permeability of the pleural microvessels and involvement of local lymph nodes causing reduced fluid reabsorption. MPE is defined by the presence of malignant cells in the pleural fluid and advanced malignancy.
This is an open label, non-randomized translational phase 1-2 dose-escalation and expansion study to determine the safety, tolerability, maximum tolerated dose (MTD) and/or recommended phase 2 dose (RP2D), pharmacokinetics (PK) and pharmacodynamics (PD) of RSO-021 after intrapleural (IP) administration in patients with MPE. The study will also evaluate antitumor activity of RSO-021 in two separate expansion cohorts; (1) in patients with MPE (non-mesothelioma) and (2) in patients with MPE from mesothelioma.
REC name
South Central - Oxford A Research Ethics Committee
REC reference
21/SC/0214
Date of REC Opinion
27 Sep 2021
REC opinion
Further Information Favourable Opinion