A Phase 2 Study of DZD8586 Combination Therapy in Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma (CLL/SLL)
Status: Recruiting
Location: See all (15) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY
This is a phase 2 study to investigate the efficacy and safety of DZD8586 in combination in participants with CLL/SLL. This study consists of two parts: Part A is the safety lead-in phase, and Part B is the dose expansion phase.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Male and female ≥ 18 years of age.
• ECOG performance status 0-2, and life expectancy ≥ 6 months.
• Confirmed newly diagnosis or treatment naïve CLL/SLL with indication for treatment.
• Patients with SLL must have at least one measurable lesion.
• Adequate bone marrow reserve and organ functions.
• Willing to comply with contraceptive restrictions.
Locations
Other Locations
China
Peking University Third Hospital
RECRUITING
Beijing
The First Bethune Hospital of Jilin University
NOT_YET_RECRUITING
Changchun
Hunan Cancer Hospital
RECRUITING
Changsha
The First People's Hospital of Changzhou
RECRUITING
Changzhou
West China Hospital of Sichuan University
RECRUITING
Chengdu
Nanfang Hospital, Southern Medical University
RECRUITING
Guangzhou
Zhujiang Hospital of Southern Medical University
RECRUITING
Guangzhou
The First Affiliated Hospital, Zhejiang University School of Medicine
RECRUITING
Hangzhou
Anhui Provincial Cancer Hospital
RECRUITING
Hefei
The First Affiliated Hospital of Nanchang University
RECRUITING
Nanchang
Affiliated Hospital of Nantong University
RECRUITING
Nantong
Shengjing Hospital of China Medical University
NOT_YET_RECRUITING
Shenyang
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
RECRUITING
Wuhan
Yichang Central People's Hospital
RECRUITING
Yichang
Henan Cancer Hospital
RECRUITING
Zhengzhou
Contact Information
Primary
Ling Zhou
ling.zhou@dizalpharma.com
0086-21-61095755
Time Frame
Start Date: 2025-09-22
Estimated Completion Date: 2030-01
Participants
Target number of participants: 66
Treatments
Experimental: Combination of DZD8586 and Venetoclax
DZD8586 will be taken orally once daily on days 1-28 of each cycle. Venetoclax will be taken orally once daily on days 1-28 starting from cycle 4 day 1.
Related Therapeutic Areas
Sponsors
Leads: Dizal (Jiangsu) Pharmaceutical Co., Ltd.