DZD8586 in Patients With Relapsed or Refractory CLL/SLL (TAI-SHAN8)
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
1 other identifier
interventional
155
1 country
17
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Apr 2024
Typical duration for phase_2
17 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 29, 2024
CompletedFirst Submitted
Initial submission to the registry
August 1, 2024
CompletedFirst Posted
Study publicly available on registry
August 6, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 1, 2028
December 1, 2025
November 1, 2025
3.3 years
August 1, 2024
November 24, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Objective Response Rate assessed by investigators
assessed up to 2 years
Secondary Outcomes (1)
Incidence of adverse event
30 days after the last dose, assessed up to 2 years
Study Arms (3)
Daily dose of DZD8586 at 25 mg
EXPERIMENTALDaily dose of DZD8586 at 50 mg
EXPERIMENTALDaily dose of DZD8586 at 75 mg
EXPERIMENTALInterventions
Daily oral dose of DZD8586 at 25 mg.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Participants who meet any of the following criteria:
- CNS involvement or Richter transformation.
- Stem cell transplantation, cell therapy, or gene therapy within 90 days. Approved small molecule therapy within 5 half-lives, monoclonal antibodies and antibody-drug conjugates within 28 days.
- Major surgery or significant traumatic injury within 4 weeks. Live attenuated vaccines or viral vector vaccines within 4 weeks.
- Take vitamin K antagonists or take more than 2 anticoagulants or antiplatelet drugs at the same time. Take proton pump inhibitors or strong CYP3A inhibitors or inducers.
- Active infection.
- Clinically significant cardiac disorders or abnormalities. History of thrombotic diseases, stroke or intracranial hemorrhage within 6 months.
- Nausea and vomiting not controlled or chronic gastrointestinal diseases, unable to swallow the formulated product or previous bowel resection that would preclude adequate absorption.
- Another malignancy within 2 years prior to enrollment with the exception of adequately treated in-situ carcinoma of the cervix, uterus, basal or squamous cell carcinoma or non-melanomatous skin cancer.
- Women who are breast feeding.
- History of hypersensitivity to active or inactive excipients of DZD8586 or drugs with a similar chemical structure or class.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (17)
Research Site
Hefei, Anhui, China
Research Site
Beijing, Beijing Municipality, 100053, China
Research Site
Beijing, Beijing Municipality, 100191, China
Research Site
Guangzhou, Guandong, 510280, China
Research Site
Guangzhou, Guandong, 510515, China
Research Site
Zhengzhou, Henan, China
Research Site
Wuhan, Hubei, China
First Affiliated Hospital of Nanjing Medical University, Jiangsu Province Hospital
Nanjing, Jiangsu, China
Research Site
Changchun, Jilin, China
Research Site
Dalian, Liaoning, China
Research Site
Shenyang, Liaoning, China
Research Site
Jinan, Shandong, China
Research Site
Linyi, Shandong, China
Research Site
Shanghai, Shanghai Municipality, China
Research Site
Taiyuan, Shangxi, China
Research Site
Tianjin, Tianjin Municipality, 300020, China
Research Site
Tianjin, Tianjin Municipality, 300060, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jianyong Li
First Affiliated Hospital of Nanjing Medical University, Jiangsu Province Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 1, 2024
First Posted
August 6, 2024
Study Start
April 29, 2024
Primary Completion (Estimated)
September 1, 2027
Study Completion (Estimated)
March 1, 2028
Last Updated
December 1, 2025
Record last verified: 2025-11
Data Sharing
- IPD Sharing
- Will not share