PURPOSE: The primary objective is to evaluate the efficacy and safety of RSO-021 in participants with Malignant Pleural Effusion Due to Advanced/Metastatic Solid Tumors Including Mesothelioma.
Multicenter trial currently available in the United Kingdom
DATES: Starts: March 31, 2022 | Ends: April 1, 2025
reference number
NCT05278975
Phase 2: Patient Cohorts
All patients should not have had prior pleurodesis and should be expected to drain at least 100ml pleural fluid.
Cohort 1: Pts with malignant pleural effusion from any non-mesothelioma solid tumour. Disease burden that is predominantly lung. Must have progressed on at least 1 prior line of systemic therapy
Cohort 3: Pts with MPE due to mesothelioma who have progressed on at least 1 prior line of systemic therapy.
Cohort 2: Pts with MPE associated with either breast, ovarian, or lung cancer. Must have progressed on at least 1 prior line of systemic therapy and have no contraindications to paclitaxel.
Cohort 4: Pts with MPE due to mesothelioma prior to systemic first line therapy.
Patient Inclusion
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Male or female ≥ 18 years
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ECOG performance status 0-1
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Histological diagnosis of MPE caused by non-mesothelioma solid tumor (expansion cohort only) or mesothelioma.
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MPE must be considered the priority for symptom control.
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Received at least 1 prior standard of care treatment regimen, with documented progression and no approved alternative available; or have mesothelioma and be treatment naive.
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Resolution of all acute reversible toxic effects of prior therapy to Grade ≤1
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Dose Escalation: Paraffin block of most recent biopsy
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Dose Expansion: Fresh tumor biopsy during screening and after third dose (optional).
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Adequate organ function as defined by lab values
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Postmenopausal or surgically sterile, or be willing to practice highly effective methods of birth control
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Willingness and ability to comply with schedule/procedures
Patients can ask their healthcare provider about Mitope Clinical Trial
Accepting Patient Referrals
By choosing to participate in the Mitope clinical trial, patients will have access to novel therapies, that has the potential to be more effective than standard treatments and contribute to research for the future. Professional healthcare providers can refer patients by contacting us mitope@rsoncology.com