This study will treat patients with non-Hodgkin B-cell lymphoma who have relapsed from, refractory or intolerant to prior therapy. This study will help understand what type of side effects may occur with the drug treatment. It will also measure the levels of drug in the body and preliminarily assess its anti-cancer activity as monotherapy.
A Phase I/II, Open-Label, Multicenter Study to Assess the Safety, Tolerability, Pharmacokinetics and Anti-tumor Efficacy of DZD9008 in Patients with Non-Hodgkin B-cell Lymphoma. This study includes dose escalation (Part A) and dose expansion (Part B).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Daily dose of DZD9008, except for cycle 0 of Part A, in which a single dose of DZD9008 is administrated. Starting dose of DZD9008 is 50 mg once daily. If tolerated, subsequent cohorts will test increasing doses of DZD9008.
Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences
Nanjing, China
Jiangsu Province Hospital - Haematology
Nanjing, China
Part A: Incidence of Treatment-Emergent Adverse Events
Incidence of Treatment-Emergent Adverse Events as Assessed by CTCAE v5.0
Time frame: Through study completion, an average of 1.5 years
Part B: objective response rate (ORR)
Time frame: Through study completion, an average of 1.5 years
Maximum Plasma DZD9008 concentration
Time frame: up to 16 weeks
Plasma DZD9008 concentration- Area Under the Curve
Time frame: up to 16 weeks
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