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)

Dizal Pharmaceuticals

Summary

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.

Eligibility

Age range: 18+ years
Sex: All
Healthy volunteers: No

Detailed criteria

Inclusion Criteria: 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 Criteria: 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 transplanta…

Interventions

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

Locations (5)

Research site
New York, New York
Research site
Albury, New South Wales
Research site
Ballarat, Victoria
Research site
Melbourne, Victoria
Research site
Perth, Western Australia

Compensation

Estimated

~$10 – $8,750

Arctuva estimate

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Details

NCT ID: NCT05824585
Type: Drug
Last updated: 8/11/2025