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

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.

Timeline

Start

2022-03-31

Primary completion

2025-04-01

Completion

2025-04-01

Outcome

Met primary endpoint

paper Primary endpoints of safety, tolerability and dose finding were met PMID 42448681 ↗

Publications

• Gibson V, Dzialo J, Messier T, Bzura A, Poile C, Rogel J, Hahne JC, Habibovic A, Stead S, Saaman A, Blyth KG, Szlosarek PW, Lord S, Thistlethwaite F, Zhang M, Nakas A, Wells-Jordan P, Kutywayo K, Butnor KJ, Heintz NH, Naumov GN, Dungey M, Colomina JH, Aktas B, Dulloo S, Spicer J, Fennell DA, Cunniff B. Preclinical characterization and phase 1 clinical testing of targeting mitochondrial peroxiredoxin 3 in cancer. Nat Commun. 2026 Jul 14;17(1):5929. doi: 10.1038/s41467-026-75153-y.

Drugs

Indications