A Phase Ib, Open Label, Multicenter Clinical Study to Evaluate the Safety, Tolerance, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of JMKX000197 Injection in the Treatment of Malignant Pleural Effusion
A Phase Ib Study to Evaluate the Safety, Tolerance, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of JMKX000197 Injection in the Treatment of Malignant Pleural Effusion
• The participant voluntarily joined the study, signed an informed consent form, and had good compliance.
• Age ≥ 18 years and ≤ 75 years old, regardless of gender.
• Participants with advanced solid tumors diagnosed by histopathology or cytopathology.
• Malignant pleural effusion confirmed by histopathology or cytopathology or clinically diagnosed as moderate or above and requiring drainage.
• Eastern Cooperative Oncology Group (ECOG) performance status: 0 to 2.
• Life expectancy of at least 3 months.
• Adequate organ function.
• Female participants of childbearing potential should agree to use contraception to prevent pregnancy until 6 months after discontinuation of JMKX000197. The serum pregnancy test result should be negative 7 days before enrollment and must be a non-lactating participant. Male participants must agree to use effective contraception during the study and for 6 months after discontinuation of JMKX000197.