RSO-021 Phase ½ Clinical Trial
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
Treatment type
Second line and beyond
Dose Escalation
RSO-021 administered in increasing doses as a solution for pleural infusion through an indwelling IP catheter, administered as a single dose on Day 1 of each week of a 21-day treatment cycle
Location
6+ UK referring sites
Primary Objective
- Safety
- Tolerability
- Toxicity profile
Condition
Malignant Pleural Effusion, Malignant Pleural Mesothelioma, Mesothelioma Solid Tumor
Drug RSO-021
A naturally-occurring, sulfur-rich, cyclic oligopeptide antibiotic of the thiopeptide class.
Investigators
Chief Investigator:
Dr. James Spicer (Guy's Hospital London),
Principal Investigators:
Dr. Alastair Greystoke (Newcastle Univ.),
Dr. Fiona Thistlethwaite (The Christie, Manchester),
Dr. Simon Lord (Oxford Univ.),
Dr. Dean Fennell (Univ. of Leicester),
Dr. Peter Szlosarek (St. Barth's London)
Description: This is an open label, non-randomized translational phase 1/2 dose- escalation and expansion study to determine the safety, tolerability, maximum tolerated dose and/or recommended phase 2 dose, pharmacokinetics and pharmacodynamics of RSO- 021 after intrapleural administration in patients with MPE. Patients must also have received and progressed on at least 1 standard line of treatment. The study will also evaluate antitumor activity of RSO-021 in two separate expansioncohorts; (1) in patients with MPE (non-mesothelioma) and (2) in patients with MPE from mesothelioma (up to 42 patients total for both cohorts).
Read more about MITOPE
US NIH: clinicaltrials.gov NCT05278975
Mesothelioma UK: mesothelioma.uk.com
NIHR UK: bepartofresearch.nihr.ac.uk
CONTACT
MITOPE management team at MITOPE@rsoncology.com