Phase Ib Study to Assess Safety and Effectiveness of JMKX000197 Injection for Treating Malignant Pleural Effusion in Adults

What this Trial Is About

Researchers are studying malignant pleural effusion, a condition where fluid builds up around the lungs in patients with advanced solid tumors. This research is a Phase Ib clinical trial aiming to evaluate the safety, tolerance, how the body processes the drug, and preliminary effectiveness of JMKX000197 injection as a treatment option. The study also seeks to determine the recommended dose for future trials. Participants will receive either one of two doses of JMKX000197 injected into the pleural space or undergo tube thoracostomy drainage, a procedure to remove fluid from around the lungs. This open-label, randomized trial takes place at multiple centers and compares these interventions to understand their effects on malignant pleural effusion. During the study, participants will be closely monitored for adverse events and their response to treatment up to 36 days initially, with follow-up lasting up to 24 months to assess survival and fluid control. Pharmacokinetic testing will measure drug levels in the body during the first week. Researchers will collect various health data including overall survival, response of the pleural effusion, and how long patients remain free from needing drainage procedures.

A Phase Ib Study of JMKX000197 Injection in the Treatment of Malignant Pleural Effusion