Assessing an Oral Bruton Tyrosine Kinase Inhibitor, DZD9008 in Patients Who Have Non-Hodgkin B-cell Lymphoma (WU-KONG3)
- Registration Number
- NCT04148742
- Lead Sponsor
- Dizal Pharmaceuticals
- Brief Summary
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.
- Detailed Description
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).
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- 120
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description daily dose of DZD9008 DZD9008 daily dose of DZD9008
- Primary Outcome Measures
Name Time Method Part B: objective response rate (ORR) Through study completion, an average of 1.5 years Part A: Incidence of Treatment-Emergent Adverse Events Through study completion, an average of 1.5 years Incidence of Treatment-Emergent Adverse Events as Assessed by CTCAE v5.0
- Secondary Outcome Measures
Name Time Method Maximum Plasma DZD9008 concentration up to 16 weeks Plasma DZD9008 concentration- Area Under the Curve up to 16 weeks
Trial Locations
- Locations (2)
Jiangsu Province Hospital - Haematology
🇨🇳Nanjing, China
Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences
🇨🇳Nanjing, China