Study of RSO-021 in Patients With Malignant Pleural Effusion Due to Advanced/Metastatic Solid Tum… (NCT05278975) | Clinical Trial Compass
UnknownPhase 1/2
Study of RSO-021 in Patients With Malignant Pleural Effusion Due to Advanced/Metastatic Solid Tumors Including Mesothelioma
United Kingdom186 participantsStarted 2022-03-31
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Male or female ≥ 18 years old.
✓. ECOG performance status 0-1.
✓. Histological diagnosis of solid tumor/mesothelioma with MPE.
✓. only patients with breast cancer, ovarian cancer or non-small cell lung cancer.
✓. patients for whom paclitaxel is a recommended SoC therapy.
✓. no contraindications to paclitaxel.
✓. Patients with a disease burden that is predominantly pleural, and a pleural space that is accessible.
✓. Patients enrolled in the mesothelioma expansion phase will be requested to undergo a tumor biopsy during the screening period and after the third dose.
Exclusion criteria
✕. Last dose of prior anti-cancer therapies:
✕. Systemic anti-cancer therapy within 3 weeks or 5 half-lives prior to study entry, whichever is shorter.
✕. Thoracic radiation therapy or significant surgery within 3 weeks prior to study entry. Localized palliative radiotherapy for pain control in non-target lesions is allowed during the screening period.
✕. Received an investigational product or been treated with an investigational device within 30 days prior to first drug administration or plans to participate in any other clinical trial while on this study.
✕. Previous or concurrent malignancy that would prevent evaluation of the primary endpoint (e.g. R/R hematological malignancy).
✕. Patients whose extent of tumor or loculations would render intrapleural administration incomplete and/or ineffective.
✕. Known hypersensitivity to the active ingredient or any excipient contained in the drug formulation.
✕. History or clinical evidence of any surgical or medical condition which the investigator and/or medical monitor judges as likely to interfere with the results of the study or pose an additional risk in participating, e.g., rapidly progressive or uncontrolled disease involving a major organ system-vascular, cardiac, pulmonary, gastrointestinal, gynecologic, hematologic, neurologic, neoplastic, renal, endocrine, or an immunodeficiency, or clinically significant active psychiatric or abuse disorders.