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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

Trial Profile

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: Recruiting
Phase of Trial: Phase I/II

Latest Information Update: 13 Jun 2025

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At a glance

  • Drugs Paclitaxel (Primary) ; Thiostrepton (Primary)
  • Indications Malignant pleural effusion; Mesothelioma; Solid tumours
  • Focus Adverse reactions; First in man
  • Acronyms MITOPE
  • Sponsors RS Oncology

Most Recent Events

  • 30 Apr 2025 Results evaluating the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary anti-tumor activity of RSO-021 presented at the 116th Annual Meeting of the American Association for Cancer Research.
  • 25 Oct 2024 Study design presented at the 36th EORTC-NCI-AACR Symposium on molecular targets and cancer therapeutics
  • 04 Jun 2024 Results (n=15) assessing safety and identify the maximum tolerated dose (MTD) of intra-pleural RSO-021 in patients with mesothelioma, or other predominantly pleural cancer, with pleural effusion were presented at the 60th Annual Meeting of the American Society of Clinical Oncology.

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