A Phase 1/2, Open-label, Multicenter Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Anti-tumor Efficacy of DZD8586 in Patients with Relapsed or Refractory B-cell Non-Hodgkin Lymphoma (B-NHL)

Dizal Pharmaceuticals1 site in 1 country17 target enrollmentJune 1, 2022

ConditionsLymphoma, Non-Hodgkin

InterventionsDZD8586

DrugsDZD8586

Overview

Phase: Phase 1
Intervention: DZD8586
Conditions: Lymphoma, Non-Hodgkin
Sponsor: Dizal Pharmaceuticals
Enrollment: 17
Locations: 1
Primary Endpoint: Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]).
Status: Completed
Last Updated: last year

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

This study is designed to evaluate the safety, tolerability, pharmacokinetic profile, and antitumor efficacy of DZD8586 in participants with relapsed or refractory B-NHL.

Registry

clinicaltrials.gov

Start Date

June 1, 2022

End Date

February 29, 2024

Last Updated

last year

Study Type

Interventional

Study Design

Sequential

Sex

All

Investigators

Sponsor

Dizal Pharmaceuticals

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•All participants must provide a signed and dated written informed consent form prior to any study-specific procedures, sampling, and analysis.
•Male and female participants must be ≥ 18 years of age when signing the informed consent form.
•ECOG performance status score of 0 - 2 points and no disease deterioration in the past two weeks.
•Participants with relapsed or refractory B-NHL must be cytologically or histologically confirmed.
•Adequate bone marrow reserve (no blood transfusion within 7 days of the pre-enrollment visit, and no use of any stimulating factor or erythropoietin) and organ function.
•Participants should be able to follow the requirements of this study for medication use and follow-up.
•Female spouses (partners) of male participants who may become pregnant should use barrier contraception (such as condoms) during the participants' participation in the trial and within 6 months after the end of dosing. Male participants should also refrain from donating sperms during participation in the trial and within 6 months after the end of dosing.
•Female participants should use adequate contraception such as abstinence, tubal ligation, use of hormonal contraception with a known lower risk of drug-drug interaction \[levonorgestrel intrauterine device (Mirena), medroxyprogesterone injection (Depo Provera)\], copper-containing intrauterine device, and partner's vasectomy during the trial and within 3 months after the end of the trial.

Exclusion Criteria

•Have unresolved adverse drug reactions (except for alopecia) of higher than grade 1 (as defined by CTCAE v5.0) before the start of dosing in the study.
•A history of anticancer treatment within washout period as defined in the protocol.
•Participants with B-NHL other than CNSL who have central nervous system or intraocular lymphoma lesions.
•Participants with CNSL who have the following health conditions:
•Unable to cooperate with a lumbar puncture or cerebrospinal fluid test.
•Involvement of sites outside the CNS requiring systemic therapy.
•Participants with condition requiring systemic glucocorticoid therapy at a dose of \> 8 mg/day (dexamethasone equivalent dose); or participants requiring immunosuppressant or biologic therapy.
•Active infectious diseases, including HBC, HCV, HIV, TB, etc.
•Abnormal heart and lung function.
•Refractory nausea and vomiting not well controlled by supportive care, chronic gastrointestinal disease, dysphagia, or previous surgical resection of bowel segments that may interfere with adequate drug absorption.

Arms & Interventions

DZD8586

Intervention: DZD8586

Outcomes

Primary Outcomes

Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]).

Time Frame: 30 days after the last dose, assessed up to 2 years

Secondary Outcomes

Plasma and cerebral spinal fluid concentrations of DZD8586(Through cycle 0 day 1 (8 days for Cycle 0, 28 days for Cycle 1, then 21 days for each subsequent cycle, up to Cycle 4))
Objective Response Rate(Through cycle 3 day 1 for non-CNSL or Cycle 1 day 15 for CNSL(21 days for each subsequent cycle, assessed up to 2 years))