Lymphoma, Non-HodgkinPhase 1/2NCT05844956
A Study of DZD8586 in Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma (TAI-SHAN1)
A Phase 1/2 study testing DZD8586 in people with Lymphoma, Non-Hodgkin, run by Dizal Pharmaceuticals at 6 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lymphoma, Non-Hodgkin
- What is being tested?
- DZD8586
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 6 sitesChina
- Study dates
- 1 Jun 2022to 29 Feb 2024
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
China6 sites
Research Site
Beijing, Beijing Municipality, 100142
Research Site
Beijing, Beijing Municipality, 100191
Research Site
Guangzhou, Guangdong, 510080
Research Site
Hangzhou, Zhejiang, 310022
Research Site
Nanjing, Jiangsu, 210000
Research Site
Zhengzhou, Henan, 450008
About this study
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)
This study is designed to evaluate the safety, tolerability, pharmacokinetic profile, and antitumor efficacy of DZD8586 in participants with relapsed or refractory B-NHL.
- Conditions
- Lymphoma, Non-Hodgkin
- Being tested
- DZD8586
- Medical subject headings
- Lymphoma, Non-Hodgkin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DZD8586Drug
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.
| Study group | Role | What they receive |
|---|---|---|
| DZD8586 | Experimental | Not described Receives: Drug: DZD8586 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]).
Measured: 30 days after the last dose, assessed up to 2 years
Secondary outcomes (2)
Plasma and cerebral spinal fluid concentrations of DZD8586
Measured: 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
Measured: 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2023
- Study start1 Jun 2022
- Primary completion29 Feb 2024
- Study completion29 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lymphoma, Non-HodgkinStudies of the same condition, open and under way.
- More trials run by Dizal PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Model description
- Dosages include 10 mg, 25 mg, 50 mg, 100 mg, and 150 mg.
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dizal Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Anne Zhang, Study director, Dizal Pharma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05844956
- Sponsor's protocol ID
- DZ2021B0001
- Status last verified
- Feb 2025
- First submitted
- 25 Apr 2023
- Last updated
- 21 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT05844956
- Acronym / sponsor ID
- DZ2021B0001
- Conditions
- Lymphoma, Non-Hodgkin
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Dizal PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 29 Feb 2024 (actual)
- Study completion
- 29 Feb 2024 (actual)
- First posted
- 6 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is designed to evaluate the safety, tolerability, pharmacokinetic profile, and antitumor efficacy of DZD8586 in participants with relapsed or refractory B-NHL.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Dosages include 10 mg, 25 mg, 50 mg, 100 mg, and 150 mg.
| Arm | Type | Receives |
|---|---|---|
| DZD8586 | Experimental | Drug: DZD8586 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (17 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DZD8586Daily 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. | Drug | DZD8586 |
Primary outcome
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]).
Time frame: 30 days after the last dose, assessed up to 2 years
2 secondary outcomes
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anne Zhang study director
Dizal Pharma
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing DZD8586 in people with Lymphoma, Non-Hodgkin, run by Dizal Pharmaceuticals at 6 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]). (time frame: 30 days after the last dose, assessed up to 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2025.