NCT06539195CompletedPhase 2
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 enrollmentStarted: March 13, 2024Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Enrollment
- 59
- Locations
- 14
- Primary Endpoint
- Objective Response Rate assessed by investigators
Study 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Sequential
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
- •History of hypersensitivity to active or inactive excipients of DZD8586 or drugs with a similar chemical structure or class.
Arms & Interventions
Daily dose of DZD8586 at 25 mg
Experimental
Intervention: DZD8586 (Drug)
Daily dose of DZD8586 at 50 mg
Experimental
Intervention: DZD8586 (Drug)
Daily dose of DZD8586 at 75 mg
Experimental
Intervention: DZD8586 (Drug)
Outcomes
Primary Outcomes
Objective Response Rate assessed by investigators
Time Frame: Assessed up to 2 years
Secondary Outcomes
- Incidence of adverse events(30 days after the last dose, assessed up to 2 years)
Investigators
Study Sites (14)
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