A Phase Ib Study to Evaluate the Safety, Tolerance, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of JMKX000197 Injection in the Treatment of Malignant Pleural Effusion
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
30
for pleural perfusion
Tube thoracostomy drainage
Cancer Hospital, Chinese Academy of Medical Sciences
Beijing, China
RECRUITINGAEs or SAEs
Time frame: Up to approximately 36 days
Recommended Phase II dose (RP2D)
Time frame: Up to approximately 24 months
Puncture /drainage-Free Survival (PuFS)
Time frame: Up to approximately 24 months
Pleural effusion overall response (ORR)
Time frame: Up to approximately 24 months
Overall survival (OS)
Time frame: Up to approximately 24 months
Pharmacokinetics (Cmax)
Time frame: Up to approximately 7 days
Pharmacokinetics(Tmax)
Time frame: Up to approximately 7 days
Pharmacokinetics (t1/2)
Time frame: Up to approximately 7 days
Pharmacokinetics (AUC0-inf)
Time frame: Up to approximately 7 days
Pharmacokinetics (AUC0-t)
Time frame: Up to approximately 7 days
Amount of Drug Excreted Via Urine and Excrement
Time frame: Up to approximately 48 hours
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