This is a Phase I/II, single-arm, multicenter, open-label study which is divided into two portions: Phase I is dose escalation portion, in which subjects with relapsed or refractory B-cell lymphoma will be enrolled except malignant lymphoblastic lymphoma (LBL) and Burkitt lymphoma. After the RP2D is identified, Phase II of subjects with relapsed or refractory mantle cell lymphoma who previously received ≥ 2 and ≤ 4 different chemotherapy and/or targeted drug therapy will be enrolled.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
8
MS-553 oral tablet BID x 28-days
Beijing Cancer Hospital
Beijing, China
Incidence of dose limiting toxicity (DLT)
Time frame: First cycle (28 days)
Incidence and severity of adverse events
Time frame: up to 24 months
To determine the MTD and RP2D of oral MS-553 in patients with BCL
Time frame: about 8 months
Objective response rate (ORR)
Time frame: up to 24 months
Duration of response (DOR)
Time frame: up to 24 months
progression-free survival (PFS)
Time frame: up to 24 months
overall survival (OS)
Time frame: up to 24 months
time to progression (TTR)
Time frame: up to 24 months
disease control rate (DCR)
Time frame: up to 24 months
Pharmacokinetics parameters: Cmax
Time frame: within the first 2 cycles (56 days)
Pharmacokinetics parameters: Tmax
Time frame: within the first 2 cycles (56 days)
Pharmacokinetics parameters: T1/2
Time frame: within the first 2 cycles (56 days)
Pharmacokinetics parameters: AUC0-12
Time frame: within the first 2 cycles (56 days)
Pharmacokinetics parameters: CL/F
Time frame: within the first 2 cycles (56 days)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.