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Completed

NCT Number: NCT05824585

DZD8586 in Patients With Relapsed or Refractory B-cell Non-Hodgkin Lymphoma

This study will treat patients with B-NHL who have relapsed, progressed, or were intolerant to systemic therapy progressed following prior therapy. This study 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 and assess its anti-cancer activity as monotherapy.

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Key information

Conditions

Lymphoma, Non-Hodgkin Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoma Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Research site, Albury, New South Wales, Australia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male or female participants who have provided ICF with age ≥ 18 yrs
  • ECOG performance 0-2, no deterioration in the past 2 weeks
  • Participants with relapsed or refractory B-NHL must have cytologically or histologically confirmed B-cell lymphoma
  • Adequate bone marrow reserve and organ system functions
  • Participants willing to comply with contraceptive restrictions

Exclusion criteria

  • Any unresolved > Grade 1 adverse event at the time of starting study treatment with the exception of alopecia.
  • Prior history of allogeneic hematopoietic stem cell transplantation
  • Stem cell transplantation, cell therapy, or gene therapy within 90 days. Approved small molecule therapy within 5 half-lives, investigational small molecule therapy within 14 days. Monoclonal antibodies and antibody-drug conjugates within 28 days Radiation therapy within 1 weeks
  • Live attenuated vaccines or viral vector vaccines within 4 weeks. Major surgery or significant traumatic injury within 4 weeks. History of stroke or intracranial hemorrhage within 6 months
  • Participants with non-CNSL presence of CNS or intraocular lymphoma lesions.
  • CNSL participants with systemic presence of lymphoma, unable to complete lumbar puncture, under systemic corticosteroids at a dose > 8 mg/day (dexamethasone equivalent dose) within 14 days or requiring immunosuppressive or biologic therapy."
  • Participants with infectious disease:
  • Clinically significant cardiac disorders or abnormalities
  • Another malignancy within 5 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.
  • Refractory nausea and vomiting if not controlled by supportive therapy, chronic gastrointestinal diseases, inability to swallow the formulated product or previous significant bowel resection that would preclude adequate absorption
  • Women who are breast feeding
  • Psychological, familial, sociological, or geographical conditions that do not permit compliance with the protocol

Treatment and study plan

DZD8586

Drug

DZD8586 treatment starting from 50 mg once daily. If tolerated, subsequent cohorts will test increasing doses of DZD8586.

Primary outcomes

  1. Part A: Incidence of adverse events

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

  2. Part B: Objective Response Rate assessed by investigators

    Time frame: assessed up to 2 years

Secondary outcomes

  1. Part A: Objective Response Rate assessed by investigators

    Time frame: assessed up to 2 years

  2. Part A: Plasma and CSF concentration of DZD8586

    Time frame: through discontinuation of treatment up to 10 weeks

  3. Part B: Duration of Response assessed by investigators

    Time frame: from date of first documented response until the date of documented progression, assessed up to 2 years

  4. Part B: Incidence of adverse events

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

  5. Part B: Plasma and CSF concentration of DZD8586

    Time frame: through discontinuation of treatment, assessed up to 2 years

Sponsors and collaborators

Lead sponsor

Dizal Pharmaceuticals

Industry

Registry information

Official study title

A Phase 1, 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)

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Apr 21, 2023
Registry last updated
Jul 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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