Non-Hodgkin LymphomaPhase 1NCT05127811
A Phase I Study of ZN-d5 in Chinese Subjects With Non-Hodgkin Lymphoma
A Phase 1 study testing ZN-d5 in people with Non-Hodgkin Lymphoma, run by Zentera Therapeutics HK Limited at 3 sites in China.
Trial summary
A phase I dose-escalation, open-label, multicenter study to assess the safety, tolerability, clinical activity, and pharmacokinetics (PK) of ZN-d5 in Chinese subjects with non-Hodgkin lymphoma (NHL). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-Hodgkin Lymphoma
- What is being tested?
- ZN-d5
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 3 sitesChina
- Study dates
- 21 Oct 2021to 26 May 2023
- Phase
- Phase 1
- 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
- NHL, relapsed from or refractory to at least 2 prior lines of systemic therapy (excluding radiotherapy and surgery); subjects must have failed or not be candidates for available standard therapy expected to provide clinical benefit.
- Female subjects of childbearing potential must have a negative serum pregnancy test and agree to use contraception while on study.
- Eastern Cooperative Oncology Group performance status ≤ 1.
- Adequate blood and other organ function, defined by the following criteria:
- Neutrophil count (ANC) ≥ 1.0 × 109/L.
- Platelet count ≥ 75 × 109/L at least 3 days after platelet transfusion (≥ 50 × 109/L permitted if the bone marrow is > 50% lymphoma cells).
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- Hemoglobin ≥ 8.0 g/dL.
- Coagulation parameters ≤ 1.5 × upper limit of normal (ULN).
- Liver enzymes ≤ 3 × ULN and total bilirubin ≤ 1.5 × ULN.
- Creatinine clearance ≥ 60 mL/min.
Who cannot join
- Received any of the following prior to start of ZN-d5 treatment:
- Systemic administration of antineoplastic agents (including investigational agents) within the shorter of 28 days or 5 half-lives.
- Major surgery within 28 days.
- Radiotherapy within 14 days.
- Autologous or allogeneic stem cell transplantation within 60 days, or receiving immunosuppression for active graft-versus-host disease.
- Use of strong CYP3A4 inhibitors, P-gp inhibitors or QT prolonging agents within 5 half-lives, or potent or moderate CYP3A4 inducers within 14 days.
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- Ongoing and clinically significant non-hematologic toxicity related to prior antineoplastic therapy.
- Presence of major cardiovascular system diseases (including QTcF > 480 msec).
- Positive serology for human immunodeficiency virus, hepatitis B, or hepatitis C unless no detectable hepatitis B or C viral load.
- Unable to take oral drugs or presence of severe gastrointestinal abnormalities.
- Active and uncontrolled clinically significant infection.
- Other active systemic malignancy or other severe, unstable, or poorly controlled acute or chronic medical conditions.
- Prior treatment with venetoclax or other BCL-2 inhibitors.
- Primary or secondary CNS lymphoma.
- Presence of post-transplant lymphoproliferative disease, Burkitt's lymphoma, Burkitt-like lymphoma, T lymphoblastic lymphoma and T lymphoblastic acute leukemia.
Trial locations and contacts
3 sites in 1 country.
China3 sites
BeiJing Cancer Hospital
Beijing, Beijing Municipality, 100142
Sun Yan Set University Cancer Center
Guangzhou, Guangdong
Fudan University Shanghai Cancer Hospital
Shanghai, Shanghai Municipality
About this study
Official title: A Phase I Dose Escalation Study of ZN-d5 Monotherapy in Chinese Subjects With Non-Hodgkin Lymphoma
A phase I dose-escalation, open-label, multicenter study to assess the safety, tolerability, clinical activity, and pharmacokinetics (PK) of ZN-d5 in Chinese subjects with non-Hodgkin lymphoma (NHL).
Read the detailed description
For the Phase I dose escalation study of ZN-d5, it is planned that after the starting dose, subsequent dose assignments will be made by means of a model-assisted design, until the MTD or RP2D is determined in the Chinese population.
- Conditions
- Non-Hodgkin Lymphoma
- Being tested
- ZN-d5
- 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.
ZN-d5Drug
BION design
| Study group | Role | What they receive |
|---|---|---|
| 100mg(on empty) | Experimental | Not described Receives: Drug: ZN-d5 |
| 200mg(on empty) | Experimental | Not described Receives: Drug: ZN-d5 |
| 400mg(on empty) | Experimental | Not described Receives: Drug: ZN-d5 |
| 600mg(on empty) | Experimental | Not described Receives: Drug: ZN-d5 |
| 600mg（with a meal） | Experimental | Not described Receives: Drug: ZN-d5 |
| 800mg(with a meal) | Experimental | Not described Receives: Drug: ZN-d5 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety monitoring
Incidence and severity of adverse events (AEs), graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0
Measured: until 30 days after the last dose of study drug
DLT
Dose-limiting toxicities (DLTs) observed in DLT evaluable subjects
Measured: at the end of Cycle 1
Secondary outcomes (2)
Effacy Evaluation
Efficacy as defined by the 2014 Lugano response criteria
Measured: up to 24 months
Maximum Plasma Concentration [Cmax]
Plasma PK parameters of ZN-d5
Measured: up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2021
- Study start21 Oct 2021
- Primary completion26 May 2023
- Study completion26 May 2023
Why it stopped: Sponsor's decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Hodgkin LymphomaStudies of the same condition, open and under way.
- 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
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zentera Therapeutics HK Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05127811
- Sponsor's protocol ID
- d5ZTCN100
- Status last verified
- May 2023
- First submitted
- 18 Sep 2021
- Last updated
- 2 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Dose Escalation Study of ZN-d5 Monotherapy in Chinese Subjects With Non-Hodgkin Lymphoma
- ClinicalTrials.gov ID
- NCT05127811
- Acronym / sponsor ID
- d5ZTCN100
- Conditions
- Non-Hodgkin Lymphoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor's decision
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Zentera Therapeutics HK LimitedIndustry (pharma, biotech, devices)
- Study start
- 21 Oct 2021 (actual)
- Primary completion
- 26 May 2023 (actual)
- Study completion
- 26 May 2023 (actual)
- First posted
- 19 Nov 2021 (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.
A phase I dose-escalation, open-label, multicenter study to assess the safety, tolerability, clinical activity, and pharmacokinetics (PK) of ZN-d5 in Chinese subjects with non-Hodgkin lymphoma (NHL).
Detailed description
For the Phase I dose escalation study of ZN-d5, it is planned that after the starting dose, subsequent dose assignments will be made by means of a model-assisted design, until the MTD or RP2D is determined in the Chinese population.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| 100mg(on empty) | Experimental | Drug: ZN-d5 |
| 200mg(on empty) | Experimental | Drug: ZN-d5 |
| 400mg(on empty) | Experimental | Drug: ZN-d5 |
| 600mg(on empty) | Experimental | Drug: ZN-d5 |
| 600mg（with a meal） | Experimental | Drug: ZN-d5 |
| 800mg(with a meal) | Experimental | Drug: ZN-d5 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- NHL, relapsed from or refractory to at least 2 prior lines of systemic therapy (excluding radiotherapy and surgery); subjects must have failed or not be candidates for available standard therapy expected to provide clinical benefit.
- Female subjects of childbearing potential must have a negative serum pregnancy test and agree to use contraception while on study.
- Eastern Cooperative Oncology Group performance status ≤ 1.
- Adequate blood and other organ function, defined by the following criteria:
Key exclusion criteria (15 listed)
- Received any of the following prior to start of ZN-d5 treatment:
- Ongoing and clinically significant non-hematologic toxicity related to prior antineoplastic therapy.
- Presence of major cardiovascular system diseases (including QTcF > 480 msec).
- Positive serology for human immunodeficiency virus, hepatitis B, or hepatitis C unless no detectable hepatitis B or C viral load.
- Unable to take oral drugs or presence of severe gastrointestinal abnormalities.
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 |
|---|---|---|
| ZN-d5BION design | Drug | 100mg(on empty), 200mg(on empty), 400mg(on empty), 600mg(on empty), 600mg（with a meal）, 800mg(with a meal) |
Primary outcome
Safety monitoring
Time frame: until 30 days after the last dose of study drug
Incidence and severity of adverse events (AEs), graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0
DLT
Time frame: at the end of Cycle 1
Dose-limiting toxicities (DLTs) observed in DLT evaluable subjects
2 secondary outcomes
Effacy Evaluation
Time frame: up to 24 months
Maximum Plasma Concentration [Cmax]
Time frame: up to 24 months
Results and safety
The study was stopped early (reason given: Sponsor's decision). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2023.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ZN-d5 in people with Non-Hodgkin Lymphoma, run by Zentera Therapeutics HK Limited at 3 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 10 inclusion and 15 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: stopped early, as of the sponsor's last update on 2 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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 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.
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 was stopped early (reason given: Sponsor's decision). Results are not available in the source record.
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?
Safety monitoring (time frame: until 30 days after the last dose of study drug). The study lists 2 primary outcomes in all. 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 2 Jun 2023.