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A Study of DZD8586 in Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma

Primary Purpose

Lymphoma, Non-Hodgkin

Status
Recruiting
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
DZD8586
Sponsored by
Dizal Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lymphoma, Non-Hodgkin

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: All participants must provide a signed and dated written informed consent form prior to any study-specific procedures, sampling, and analysis. Male and female participants must be ≥ 18 years of age when signing the informed consent form. ECOG performance status score of 0 - 2 points and no disease deterioration in the past two weeks. Participants with relapsed or refractory B-NHL must be cytologically or histologically confirmed. Adequate bone marrow reserve (no blood transfusion within 7 days of the pre-enrollment visit, and no use of any stimulating factor or erythropoietin) and organ function. Participants should be able to follow the requirements of this study for medication use and follow-up. Female spouses (partners) of male participants who may become pregnant should use barrier contraception (such as condoms) during the participants' participation in the trial and within 6 months after the end of dosing. Male participants should also refrain from donating sperms during participation in the trial and within 6 months after the end of dosing. Female participants should use adequate contraception such as abstinence, tubal ligation, use of hormonal contraception with a known lower risk of drug-drug interaction [levonorgestrel intrauterine device (Mirena), medroxyprogesterone injection (Depo Provera)], copper-containing intrauterine device, and partner's vasectomy during the trial and within 3 months after the end of the trial. 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: Unable to cooperate with a lumbar puncture or cerebrospinal fluid test. Involvement of sites outside the CNS requiring systemic therapy. Participants with condition requiring systemic glucocorticoid therapy at a dose of > 8 mg/day (dexamethasone equivalent dose); or participants requiring immunosuppressant or biologic therapy. 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.

Sites / Locations

  • Research SiteRecruiting
  • Research SiteRecruiting
  • Research Site
  • Research SiteRecruiting
  • Research SiteRecruiting
  • Research Site

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

DZD8586

Arm Description

Outcomes

Primary Outcome Measures

Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]).

Secondary Outcome Measures

Plasma and cerebral spinal fluid concentrations of DZD8586
Objective Response Rate

Full Information

First Posted
April 25, 2023
Last Updated
May 6, 2023
Sponsor
Dizal Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT05844956
Brief Title
A Study of DZD8586 in Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma
Official Title
A Phase 1/2, 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)
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 1, 2022 (Actual)
Primary Completion Date
April 30, 2027 (Anticipated)
Study Completion Date
October 30, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Dizal Pharmaceuticals

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
This study is designed to evaluate the safety, tolerability, pharmacokinetic profile, and antitumor efficacy of DZD8586 in participants with relapsed or refractory B-NHL.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphoma, Non-Hodgkin

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Sequential Assignment
Model Description
Dosages include 10 mg, 25 mg, 50 mg, 100 mg, and 150 mg.
Masking
None (Open Label)
Allocation
N/A
Enrollment
386 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
DZD8586
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
DZD8586
Intervention Description
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.
Primary Outcome Measure Information:
Title
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]).
Time Frame
30 days after the last dose, assessed up to 2 years
Secondary Outcome Measure Information:
Title
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)
Title
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)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: All participants must provide a signed and dated written informed consent form prior to any study-specific procedures, sampling, and analysis. Male and female participants must be ≥ 18 years of age when signing the informed consent form. ECOG performance status score of 0 - 2 points and no disease deterioration in the past two weeks. Participants with relapsed or refractory B-NHL must be cytologically or histologically confirmed. Adequate bone marrow reserve (no blood transfusion within 7 days of the pre-enrollment visit, and no use of any stimulating factor or erythropoietin) and organ function. Participants should be able to follow the requirements of this study for medication use and follow-up. Female spouses (partners) of male participants who may become pregnant should use barrier contraception (such as condoms) during the participants' participation in the trial and within 6 months after the end of dosing. Male participants should also refrain from donating sperms during participation in the trial and within 6 months after the end of dosing. Female participants should use adequate contraception such as abstinence, tubal ligation, use of hormonal contraception with a known lower risk of drug-drug interaction [levonorgestrel intrauterine device (Mirena), medroxyprogesterone injection (Depo Provera)], copper-containing intrauterine device, and partner's vasectomy during the trial and within 3 months after the end of the trial. 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: Unable to cooperate with a lumbar puncture or cerebrospinal fluid test. Involvement of sites outside the CNS requiring systemic therapy. Participants with condition requiring systemic glucocorticoid therapy at a dose of > 8 mg/day (dexamethasone equivalent dose); or participants requiring immunosuppressant or biologic therapy. 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Frank Fang
Phone
021-61095801
Email
frank.fang@dizalpharma.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anne Zhang
Organizational Affiliation
Dizal Pharma
Official's Role
Study Director
Facility Information:
Facility Name
Research Site
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100142
Country
China
Individual Site Status
Recruiting
Facility Name
Research Site
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100191
Country
China
Individual Site Status
Recruiting
Facility Name
Research Site
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510080
Country
China
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Zhengzhou
State/Province
Henan
ZIP/Postal Code
450008
Country
China
Individual Site Status
Recruiting
Facility Name
Research Site
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210000
Country
China
Individual Site Status
Recruiting
Facility Name
Research Site
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310022
Country
China
Individual Site Status
Not yet recruiting

12. IPD Sharing Statement

Plan to Share IPD
No

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A Study of DZD8586 in Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma

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