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RecruitingLast updated: 30 November 2023

This trial is studying the use of a new drug (called DZD8586) to treat people with B-cell Non-Hodgkin Lymphoma who have relapsed, progressed, or were intolerant to prior therapyA 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)

Clinical summary

Summary

Eligible participants will receive the study drug (called DZD8586). Treatment will start from 50mg once daily. If this is tolerated, subsequent cohorts will test increasing doses.

Conditions

This trial is treating patients with relapsed or refractory B-cell Non-Hodgkin Lymphoma

Cancer

Blood Cancers Haematological

Age

People18+

Phase

I

More information

Trial Identifiers

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Trial sponsor

Dizal Pharmaceuticals

Scientific 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)

Eligibility

Inclusion

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

Exclusion

  1. Any unresolved > Grade 1 adverse event at the time of starting study treatment with the exception of alopecia.
  2. Prior history of allogeneic hematopoietic stem cell transplantation
  3. 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
  4. 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
  5. Participants with non-CNSL presence of CNS or intraocular lymphoma lesions.
  6. 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."
  7. Participants with infectious disease:
  8. Clinically significant cardiac disorders or abnormalities
  9. 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.
  10. 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
  11. Women who are breast feeding
  12. Psychological, familial, sociological, or geographical conditions that do not permit compliance with the protocol

Inclusion

  • You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.
  • You have had treatment, but your cancer has come back.

Exclusion

  • You have been diagnosed with a prior or secondary type of cancer.
  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria.

Ask your doctor if this trial could be right for you.

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