A Phase I, Open, Multicenter Clinical Study to Evaluate the Safety, Tolerance, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of JMKX000197 Injection in the Treatment of Malignant Pleural Effusion
Primary objectives: To evaluate the safety and tolerability of JMKX000197 injection in the treatment of patients with malignant pleural effusion, explore DLT of JMKX000197 treatment, and determine MTD and RP2D. Secondary objectives: To evaluate the pharmacokinetic (PK)/pharmacokinetic (PD) characteristics of JMKX000197 injection in the treatment of patients with malignant pleural effusion; To evaluate preliminarily efficacy of JMKX000197 injection in patients with malignant pleural effusion; To evaluate the drug metabolic transformation of JMKX000197 injection.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
78
for injection
Zhongnan Hospital of Wuhan University
Wuhan, Hubei, China
RECRUITINGIncidence of dose limiting toxicity
Time frame: Up to approximately 7 days at each dose level
Maximum tolerated dose
Time frame: Up to approximately 24 months
Recommended Phase II dose
Time frame: Up to approximately 24 months
Objective Response Rate(ORR)
Time frame: Up to approximately 36 days
Disease control rate, DCR
Time frame: Up to approximately 36 days
Maximum observed concentration (Cmax) of JMKX000197
Time frame: Up to approximately 7 days
Time to maximum concentration (Tmax) of JMKX000197
Time frame: Up to approximately 7 days
Half-life (t1/2) of JMKX000197
Time frame: Up to approximately 7 days
Areas under the concentration-time curve from time zero extrapolated to infinity (AUC0-inf) of JMKX000197
Time frame: Up to approximately 7 days
Areas under the concentration-time curve from time zero to the time of last quantifiable concentration (AUC0-t) of JMKX000197
Time frame: Up to approximately 7 days
Amount of Drug Excreted Via Urine and excrement During the Collection Interval 0-48 Hours Post Administration
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Time frame: Up to approximately 48 hours
Concentrations of IL-6 in plasma
Time frame: Up to approximately 36 days