This is a Phase 1a/1b, multicenter, open-label, two-part study in subjects with relapsed or refractory MM: * Phase 1a: single agent CWP232291. Dose-finding followed by cohort expansion at the maximum tolerated dose (MTD) or optimal dose as determined by the Safety Review Committee (SRC). * Phase 1b: CWP232291 in combination with lenalidomide and dexamethasone. Dose-finding followed by cohort expansion at the combination therapy MTD or optimal dose as determined by the SRC.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
25
CWP232291 administered alone twice weekly every 4 weeks.
CWP232291 administered twice weekly every 4 weeks. Lenalidomide and Dexamethasone administered per standard therapy.
The University of Texas MD Anderson Cancer Center
Houston, Texas, United States
Seoul National University Hospital
Seoul, South Korea
Seoul St.Mary's Hospital
Seoul, South Korea
Yonsei Severance Hospital
Seoul, South Korea
Recommended dose of Phase 2 trial of CWP232291
Time frame: up to 4 weeks
Cmax as a pharmacokinetic parameter of 'CWP232291'
Peak plasma concentration(Cmax) of 'CWP232291'
Time frame: Predose, 0.25, 0.5, 0.75, 1, 1.5 , 2 , 4 , 8, 12, 24 hours after the start of infusion
AUC as a pharmacokinetic parameter of 'CWP232291'
Area under the plasma concentration versus time curve (AUC) of 'CWP232291'
Time frame: Predose, 0.25, 0.5, 0.75, 1, 1.5 , 2 , 4 , 8, 12, 24 hours after the start of infusion
Cmax as a pharmacokinetic parameter of metabolites of ' CWP232204'
Peak Plasma Concentration (Cmax) of metabolites of 'CWP232291'
Time frame: Predose, 0.25, 0.5, 0.75, 1, 1.5 , 2 , 4 , 8, 12, 24 hours after the start of infusion
AUC as a pharmacokinetic parameter of metabolites of ' CWP232204'
Area under the plasma concentration versus time curve (AUC) of metabolites of 'CWP232291'
Time frame: Predose, 0.25, 0.5, 0.75, 1, 1.5 , 2 , 4 , 8, 12, 24 hours after the start of infusion
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