DZD8586 in Patients With Relapsed or Refractory Diffuse Large B-cell Lymphoma (TAI-SHAN9)
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
1 other identifier
interventional
59
1 country
14
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Mar 2024
14 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
March 13, 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
December 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2026
March 4, 2026
March 1, 2026
2.7 years
August 1, 2024
March 3, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Objective Response Rate assessed by investigators
Assessed up to 2 years
Secondary Outcomes (1)
Incidence of adverse events
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
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.
- Histologically confirmed recurrent or refractory DLBCL.
- 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
- 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. 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 (14)
Research Site
Hefei, Anhui, 230031, China
Research Site
Beijing, Beijing Municipality, 100083, China
Research Site
Guangzhou, Guangdong, 510060, China
Research Site
Nanning, Guangxi, 530016, China
Research Site
Zhengzhou, Henan, 450003, China
Research Site
Wuhan, Hubei, 430023, China
Research Site
Changsha, Hunan, 410031, China
Research Site
Jinan, Shandong, 250117, China
Research Site
Linyi, Shandong, 276002, China
Research Site
Xi’an, Shanxi, 710061, China
Research Site
Chengdu, Sichuan, 610041, China
National Clinical Research Center for Blood Diseases, Blood Disease Hospital & Institute of Hematology, Chinese Academy of Medical Sciences & Peking Union Medical College
Tianjin, Tianjin Municipality, 300020, China
Research Site
Tianjin, Tianjin Municipality, 300181, China
Research Site
Hangzhou, Zhejiang, 310009, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Lugui Qiu
National Clinical Research Center for Blood Diseases, Blood Disease Hospital & Institute of Hematology, Chinese Academy of Medical Sciences & Peking Union Medical College
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
March 13, 2024
Primary Completion (Estimated)
December 1, 2026
Study Completion (Estimated)
December 1, 2026
Last Updated
March 4, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will not share