A Phase 2, Open-label, Multicenter Study to Evaluate the Efficacy, Safety, Tolerability and Pharmacokinetics of DZD8586 in Patients With Relapsed or Refractory Diffuse Large B-cell Lymphoma
Status: Recruiting
Location: See all (16) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY
This study will treat patients with DLBCL whose disease comes back or is not responding to prior therapy. This study will assess the anti-tumor activity of DZD8586 as monotherapy. It will help to understand what type of side effects may occur with the drug treatment. It will also measure the levels of drug in the body.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
⁃ Participants who meet all the following criteria:
• Male and female ≥ 18 years of age.
• ECOG performance status 0-2.
• Histologically confirmed recurrent or refractory DLBCL.
• Adequate bone marrow reserve and organ system functions.
• Willing to comply with contraceptive restrictions
Locations
Other Locations
China
Research Site
RECRUITING
Beijing
Research Site
RECRUITING
Changsha
Research Site
RECRUITING
Chengdu
Research Site
NOT_YET_RECRUITING
Dalian
Research Site
RECRUITING
Guangzhou
Research Site
RECRUITING
Hangzhou
Research Site
RECRUITING
Hefei
Research Site
RECRUITING
Jinan
Research Site
RECRUITING
Linyi
Research Site
NOT_YET_RECRUITING
Nanjing
Research Site
RECRUITING
Nanning
National Clinical Research Center for Blood Diseases, Blood Disease Hospital & Institute of Hematology, Chinese Academy of Medical Sciences & Peking Union Medical College
RECRUITING
Tianjin
Research Site
RECRUITING
Tianjin
Research Site
RECRUITING
Wuhan
Research Site
RECRUITING
Xi’an
Research Site
RECRUITING
Zhengzhou
Contact Information
Primary
Ziyi Liu
Ziyi.Liu@dizalpharma.com
0086-21-61095852
Time Frame
Start Date: 2024-03-13
Estimated Completion Date: 2028-04
Participants
Target number of participants: 180
Treatments
Experimental: Daily dose of DZD8586 at 25 mg
Experimental: Daily dose of DZD8586 at 50 mg
Experimental: Daily dose of DZD8586 at 75 mg
Related Therapeutic Areas
Sponsors
Leads: Dizal Pharmaceuticals