Study of M701 for Malignant Pleural Effusions in Advanced NSCLC Patients Comparing Different Dosing and Standard Treatments

What this Trial Is About

Researchers are studying M701 in a phase 1b2, multicenter, open-label trial to evaluate its safety, tolerability, pharmacokinetics, pharmacodynamics, immunogenicity, and initial effectiveness in patients with malignant pleural effusions caused by advanced non-small cell lung cancer NSCLC. This trial involves patients whose cancer has progressed despite prior treatment and who require intervention for pleural effusions. The study has two phases Phase 1b includes dose escalation and cohort expansion to find the recommended dose and assess different injection frequencies. Phase 2 randomly assigns participants to receive either M701 with pleural drainage or standard treatment involving pleural drainage and possibly chemotherapy. Treatments involve pleural infusion of M701 on specific days and pleural drainage procedures. The trial evaluates outcomes like pleural effusion response and puncture-free survival. Participants will undergo regular assessments including safety monitoring, laboratory tests, tumor biomarker analysis, and quality of life questionnaires for up to one year. Researchers will track adverse events, immunogenicity, drug levels, and survival without requiring additional drainage. The study includes follow-up visits to monitor health status and treatment effects, supporting careful evaluation of M701 in this patient group.

A Phase Ib/II Clinical Trial of M701 in the Treatment of Malignant Pleural Effusions Caused by NSCLC