This study is designed to evaluate the safety, tolerability, pharmacokinetic profile, and antitumor efficacy of DZD8586 in participants with relapsed or refractory B-NHL.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
17
Daily dose of DZD8586, except for cycle 0 of Part A, in which a single dose of DZD8586 is administrated. Starting dose of DZD8586 is 10 mg once daily. If tolerated, subsequent cohorts will test increasing doses of DZD8586.
Research Site
Beijing, Beijing Municipality, China
Research Site
Beijing, Beijing Municipality, China
Research Site
Guangzhou, Guangdong, China
Research Site
Zhengzhou, Henan, China
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]).
Time frame: 30 days after the last dose, assessed up to 2 years
Plasma and cerebral spinal fluid concentrations of DZD8586
Time frame: Through cycle 0 day 1 (8 days for Cycle 0, 28 days for Cycle 1, then 21 days for each subsequent cycle, up to Cycle 4)
Objective Response Rate
Time frame: Through cycle 3 day 1 for non-CNSL or Cycle 1 day 15 for CNSL(21 days for each subsequent cycle, assessed up to 2 years)
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Research Site
Nanjing, Jiangsu, China
Research Site
Hangzhou, Zhejiang, China