A phase I dose-escalation, open-label, multicenter study to assess the safety, tolerability, clinical activity, and pharmacokinetics (PK) of ZN-d5 in Chinese subjects with non-Hodgkin lymphoma (NHL).
For the Phase I dose escalation study of ZN-d5, it is planned that after the starting dose, subsequent dose assignments will be made by means of a model-assisted design, until the MTD or RP2D is determined in the Chinese population.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
8
BION design
BeiJing Cancer Hospital
Beijing, Beijing Municipality, China
Sun Yan Set University Cancer Center
Guangzhou, Guangdong, China
Fudan University Shanghai Cancer Hospital
Shanghai, Shanghai Municipality, China
Safety monitoring
Incidence and severity of adverse events (AEs), graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0
Time frame: until 30 days after the last dose of study drug
DLT
Dose-limiting toxicities (DLTs) observed in DLT evaluable subjects
Time frame: at the end of Cycle 1
Effacy Evaluation
Efficacy as defined by the 2014 Lugano response criteria
Time frame: up to 24 months
Maximum Plasma Concentration [Cmax]
Plasma PK parameters of ZN-d5
Time frame: up to 24 months
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