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

Dizal Pharmaceuticals14 sites in 1 country59 target enrollmentMarch 13, 2024

ConditionsDiffuse Large B Cell Lymphoma

InterventionsDZD8586

Overview

Phase: Phase 2
Intervention: DZD8586
Conditions: Diffuse Large B Cell Lymphoma
Sponsor: Dizal Pharmaceuticals
Enrollment: 59
Locations: 14
Primary Endpoint: Objective Response Rate assessed by investigators
Status: Active, not recruiting
Last Updated: last month

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

March 13, 2024

End Date

December 1, 2026

Last Updated

last month

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-
•Histologically confirmed recurrent or refractory DLBCL.
•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
•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.