Status:
ACTIVE_NOT_RECRUITING
DZD8586 in Patients With Relapsed or Refractory Diffuse Large B-cell Lymphoma (TAI-SHAN9)
Lead Sponsor:
Dizal Pharmaceuticals
Conditions:
Diffuse Large B Cell Lymphoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 unde...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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.
Key Trial Info
Start Date :
March 13 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2026
Estimated Enrollment :
59 Patients enrolled
Trial Details
Trial ID
NCT06539195
Start Date
March 13 2024
End Date
August 1 2026
Last Update
December 12 2025
Active Locations (14)
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1
Research Site
Hefei, Anhui, China, 230031
2
Research Site
Beijing, Beijing Municipality, China, 100083
3
Research Site
Guangzhou, Guangdong, China, 510060
4
Research Site
Nanning, Guangxi, China, 530016