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

Dizal Pharmaceuticals2 sites in 1 country155 target enrollmentApril 29, 2024

ConditionsChronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma

InterventionsDZD8586

DrugsDZD8586

Overview

Phase: Phase 2
Intervention: DZD8586
Conditions: Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Sponsor: Dizal Pharmaceuticals
Enrollment: 155
Locations: 2
Primary Endpoint: Objective Response Rate assessed by investigators
Status: Recruiting
Last Updated: 5 months ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials Related News

Overview

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.

Registry

clinicaltrials.gov

Start Date

April 29, 2024

End Date

March 1, 2028

Last Updated

5 months ago

Study Type

Interventional

Study Design

Sequential

Sex

All

Investigators

Sponsor

Dizal Pharmaceuticals

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Participants who meet all the following criteria:
•Male and female ≥ 18 years of age.
•ECOG performance status 0-
•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.