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This study is designed to evaluate the safety, tolerability, pharmacokinetic profile, and antitumor efficacy of DZD8586 in participants with relapsed or refractory B-NHL.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DZD8586 | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DZD8586 | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]). | 30 days after the last dose, assessed up to 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
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Inclusion Criteria:
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:
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.
Participants diagnosed with other malignancies apart from B-cell lymphoma within the past 5 years. However, participants may also be enrolled if the current evidence shows that the participant has been clinically cured and the investigator believes that the potential benefit of treatment with DZD8586 outweighs the potential risk.
Participants with hypersensitivity to DZD8586 pharmaceutical excipients or other chemical analogs.
Participants with serious or poorly controlled systemic diseases as judged by the investigator or other evidence, including poorly controlled hypertension and active bleeding disorders.
Personnel involved in the planning and implementation of this study (only applicable to employees of the sponsor and study site).
Female participants who are breastfeeding or pregnant.
Participants who have taken DZD8586.
Participants should not participate in the study if they are considered by the investigator to be unlikely to comply with study procedures, restrictions, and requirements.
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| Name | Affiliation | Role |
|---|---|---|
| Anne Zhang | Dizal Pharma | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Beijing | Beijing Municipality | 100142 | China | ||
| Research Site |
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| ID | Term |
|---|---|
| D008228 | Lymphoma, Non-Hodgkin |
| ID | Term |
|---|---|
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
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Dosages include 10 mg, 25 mg, 50 mg, 100 mg, and 150 mg.
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| Beijing |
| Beijing Municipality |
| 100191 |
| China |
| Research Site | Guangzhou | Guangdong | 510080 | China |
| Research Site | Zhengzhou | Henan | 450008 | China |
| Research Site | Nanjing | Jiangsu | 210000 | China |
| Research Site | Hangzhou | Zhejiang | 310022 | China |
| D008206 |
| Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |