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Trial Title:
A Study of DZD8586 in Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma
NCT ID:
NCT05844956
Condition:
Lymphoma, Non-Hodgkin
Conditions: Official terms:
Lymphoma
Lymphoma, Non-Hodgkin
Lymphoma, B-Cell
Study type:
Interventional
Study phase:
Phase 1/Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Sequential Assignment
Intervention model description:
Dosages include 10 mg, 25 mg, 50 mg, 100 mg, and 150 mg.
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
DZD8586
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.
Arm group label:
DZD8586
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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. All participants must provide a signed and dated written informed consent form prior
to any study-specific procedures, sampling, and analysis.
2. Male and female participants must be ≥ 18 years of age when signing the informed
consent form.
3. ECOG performance status score of 0 - 2 points and no disease deterioration in the
past two weeks.
4. Participants with relapsed or refractory B-NHL must be cytologically or
histologically confirmed.
5. 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.
6. Participants should be able to follow the requirements of this study for medication
use and follow-up.
7. 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.
8. 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:
1. 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.
2. A history of anticancer treatment within washout period as defined in the protocol.
3. Participants with B-NHL other than CNSL who have central nervous system or
intraocular lymphoma lesions.
4. Participants with CNSL who have the following health conditions:
1. Unable to cooperate with a lumbar puncture or cerebrospinal fluid test.
2. Involvement of sites outside the CNS requiring systemic therapy.
3. Participants with condition requiring systemic glucocorticoid therapy at a dose
of > 8 mg/day (dexamethasone equivalent dose); or participants requiring
immunosuppressant or biologic therapy.
5. Active infectious diseases, including HBC, HCV, HIV, TB, etc.
6. Abnormal heart and lung function.
7. 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.
8. 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.
9. Participants with hypersensitivity to DZD8586 pharmaceutical excipients or other
chemical analogs.
10. Participants with serious or poorly controlled systemic diseases as judged by the
investigator or other evidence, including poorly controlled hypertension and active
bleeding disorders.
11. Personnel involved in the planning and implementation of this study (only applicable
to employees of the sponsor and study site).
12. Female participants who are breastfeeding or pregnant.
13. Participants who have taken DZD8586.
14. 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Research Site
Address:
City:
Beijing
Zip:
100142
Country:
China
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Beijing
Zip:
100191
Country:
China
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Guangzhou
Zip:
510080
Country:
China
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Zhengzhou
Zip:
450008
Country:
China
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Nanjing
Zip:
210000
Country:
China
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Hangzhou
Zip:
310022
Country:
China
Status:
Not yet recruiting
Start date:
June 1, 2022
Completion date:
October 30, 2027
Lead sponsor:
Agency:
Dizal Pharmaceuticals
Agency class:
Industry
Source:
Dizal Pharmaceuticals
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05844956
