A Phase 2, Open-label, Multicenter Study to Evaluate the Efficacy, Safety, Tolerability and Pharmacokinetics of DZD8586 in Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Status: Recruiting
Location: See all (17) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY
This study will treat patients with CLL/SLL whose disease comes back or is not responding to prior therapy, or if they can not bear side effects of the prior treatment. 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.
• Confirmed diagnosis of CLL/SLL with indication for treatment.
• 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
Beijing
Research Site
RECRUITING
Changchun
Research Site
NOT_YET_RECRUITING
Dalian
Research Site
RECRUITING
Guangzhou
Research Site
RECRUITING
Guangzhou
Research Site
RECRUITING
Hefei
Research Site
RECRUITING
Jinan
Research Site
RECRUITING
Linyi
First Affiliated Hospital of Nanjing Medical University, Jiangsu Province Hospital
RECRUITING
Nanjing
Research Site
RECRUITING
Shanghai
Research Site
RECRUITING
Shenyang
Research Site
RECRUITING
Taiyuan
Research Site
RECRUITING
Tianjin
Research Site
RECRUITING
Tianjin
Research Site
RECRUITING
Wuhan
Research Site
RECRUITING
Zhengzhou
Contact Information
Primary
Frank Fang
frank.fang@dizalpharma.com
0086-21-61095801
Time Frame
Start Date: 2024-04-29
Estimated Completion Date: 2028-03
Participants
Target number of participants: 155
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