A Phase 1/2 interventional study of DZD8586 in Lymphoma, Non-Hodgkin, sponsored by Dizal Pharmaceuticals. Completed at 6 sites in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-02-21.
Sponsored by Dizal Pharmaceuticals · Phase 1/2, Interventional, and Treatment
This study is designed to evaluate the safety, tolerability, pharmacokinetic profile, and antitumor efficacy of DZD8586 in participants with relapsed or refractory B-NHL.
2,043 studies on the registry are indexed under Lymphoma, Non-Hodgkin; 309 are open to participants now.
This study's enrollment of 17 is below the median of 40 across 1,744 interventional studies indexed under Lymphoma, Non-Hodgkin.
Browse Lymphoma, Non-Hodgkin studies →Dizal Pharmaceuticals is the lead sponsor of 39 studies on the registry; 15 are open to participants now.
Of its 14 completed or terminated interventional studies of FDA-regulated products, 1 (7%) have results posted.
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Exclusion Criteria:
Participants with CNSL who have the following health conditions:
Drug: DZD8586
Daily dose of DZD8586, except for cycle 0 of Part A, in which a single dose of DZD8586 is administrated. Starting dose of DZD8586 is 10 mg once daily. If tolerated, subsequent cohorts will test increasing doses of DZD8586.
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]).
Time frame: 30 days after the last dose, assessed up to 2 years
Plasma and cerebral spinal fluid concentrations of DZD8586
Time frame: 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
Time frame: 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)
Plan to share: No
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This study is completed, as verified in Feb 2025. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Birelentinib