DZD8586 in Patients With Relapsed or Refractory Diffuse Large B-cell Lymphoma (TAI-SHAN9)

Inclusion Criteria:

Participants who meet all the following criteria:

1. Male and female ≥ 18 years of age.

2. ECOG performance status 0-2.

3. Histologically confirmed recurrent or refractory DLBCL.

4. Adequate bone marrow reserve and organ system functions.

5. Willing to comply with contraceptive restrictions

Exclusion Criteria:

Participants who meet any of the following criteria:

1. CNS involvement

2. Stem cell transplantation, cell therapy, or gene therapy within 90 days. Approvedsmall molecule therapy within 5 half-lives. Monoclonal antibodies and antibody-drugconjugates within 28 days.

3. Major surgery or significant traumatic injury within 4 weeks. Live attenuatedvaccines or viral vector vaccines within 4 weeks.

4. Take vitamin K antagonists or take more than 2 anticoagulants or antiplatelet drugsat the same time. Take proton pump inhibitors or strong CYP3A inhibitors orinducers.

5. Active infection.

6. Clinically significant cardiac disorders. History of thrombotic diseases, stroke orintracranial hemorrhage within 6 months.

7. Nausea and vomiting not controlled or chronic gastrointestinal diseases, unable toswallow the formulated product or previous bowel resection that would precludeadequate absorption.

8. Another malignancy within 2 years prior to enrollment with the exception ofadequately treated in-situ carcinoma of the cervix, uterus, basal or squamous cellcarcinoma or non-melanomatous skin cancer.

9. Women who are breast feeding.

10. History of hypersensitivity to active or inactive excipients of DZD8586 or drugswith a similar chemical structure or class.