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Study of RSO-021 in Patients With Malignant Pleural Effusion Due to Advanced/Metastatic Solid Tumors Including Mesothelioma

NCT05278975 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 186

Last updated 2024-01-26

No results posted yet for this study

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.

Conditions

  • Malignant Pleural Effusion
  • Malignant Pleural Mesothelioma
  • Mesothelioma
  • Mesotheliomas Pleural
  • Mesothelioma; Lung
  • Pleural Effusion, Malignant

Interventions

DRUG

RSO-021

A naturally-occurring, sulfur-rich, cyclic oligopeptide antibiotic of the thiopeptide class.

Sponsors & Collaborators

  • RS Oncology LLC

    lead INDUSTRY

Principal Investigators

  • James Spicer, MD · Guys Hospital

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-03-31
Primary Completion
2025-04-01
Completion
2025-04-01

Countries

  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05278975 on ClinicalTrials.gov