DZD8586 in Patients With Relapsed or Refractory CLL/SLL (TAI-SHAN8)

Inclusion criteria

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.

Exclusion criteria

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.