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A Phase I Study of ZN-d5 in Chinese Subjects With Non-Hodgkin Lymphoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05127811
Recruitment Status : Enrolling by invitation
First Posted : November 19, 2021
Last Update Posted : November 19, 2021
Sponsor:
Information provided by (Responsible Party):
Zentera Therapeutics HK Limited

Brief 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).

Condition or disease Intervention/treatment Phase
Non-Hodgkin Lymphoma Drug: ZN-d5 Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I Dose Escalation Study of ZN-d5 Monotherapy in Chinese Subjects With Non-Hodgkin Lymphoma
Actual Study Start Date : October 21, 2021
Estimated Primary Completion Date : May 23, 2023
Estimated Study Completion Date : March 9, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma

Arm Intervention/treatment
Experimental: 100mg Drug: ZN-d5
BION design

Experimental: 200mg Drug: ZN-d5
BION design

Experimental: 400mg Drug: ZN-d5
BION design

Experimental: 600mg Drug: ZN-d5
BION design

Experimental: 800mg Drug: ZN-d5
BION design




Primary Outcome Measures :
  1. 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

  2. DLT [ Time Frame: at the end of Cycle 1 ]
    Dose-limiting toxicities (DLTs) observed in DLT evaluable subjects


Secondary Outcome Measures :
  1. Effacy Evaluation [ Time Frame: up to 24 months ]
    Efficacy as defined by the 2014 Lugano response criteria

  2. Maximum Plasma Concentration [Cmax] [ Time Frame: up to 24 months ]
    Plasma PK parameters of ZN-d5



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 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.
  2. Female subjects of childbearing potential must have a negative serum pregnancy test and agree to use contraception while on study.
  3. Eastern Cooperative Oncology Group performance status ≤ 1.
  4. Adequate blood and other organ function, defined by the following criteria:

    1. Neutrophil count (ANC) ≥ 1.0 × 109/L.
    2. Platelet count ≥ 75 × 109/L at least 3 days after platelet transfusion (≥ 50 × 109/L permitted if the bone marrow is > 50% lymphoma cells).
    3. Hemoglobin ≥ 8.0 g/dL.
    4. Coagulation parameters ≤ 1.5 × upper limit of normal (ULN).
    5. Liver enzymes ≤ 3 × ULN and total bilirubin ≤ 1.5 × ULN.
    6. Creatinine clearance ≥ 60 mL/min.

Exclusion Criteria:

  1. Received any of the following prior to start of ZN-d5 treatment:

    1. Systemic administration of antineoplastic agents (including investigational agents) within the shorter of 28 days or 5 half-lives.
    2. Major surgery within 28 days.
    3. Radiotherapy within 14 days.
    4. Autologous or allogeneic stem cell transplantation within 60 days, or receiving immunosuppression for active graft-versus-host disease.
    5. 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.
  2. Ongoing and clinically significant non-hematologic toxicity related to prior antineoplastic therapy.
  3. Presence of major cardiovascular system diseases (including QTcF > 480 msec).
  4. Positive serology for human immunodeficiency virus, hepatitis B, or hepatitis C unless no detectable hepatitis B or C viral load.
  5. Unable to take oral drugs or presence of severe gastrointestinal abnormalities.
  6. Active and uncontrolled clinically significant infection.
  7. Other active systemic malignancy or other severe, unstable, or poorly controlled acute or chronic medical conditions.
  8. Prior treatment with venetoclax or other BCL-2 inhibitors.
  9. Primary or secondary CNS lymphoma.
  10. Presence of post-transplant lymphoproliferative disease, Burkitt's lymphoma, Burkitt-like lymphoma, T lymphoblastic lymphoma and T lymphoblastic acute leukemia.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05127811


Locations
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China, Beijing
BeiJing Cancer Hospital
BeiJing, Beijing, China, 100142
China, Guangdong
Sun Yan Set University Cancer Center
Guangzhou, Guangdong, China
China, Shanghai
Fudan University Shanghai Cancer Hospital
Shanghai, Shanghai, China
Sponsors and Collaborators
Zentera Therapeutics HK Limited
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Responsible Party: Zentera Therapeutics HK Limited
ClinicalTrials.gov Identifier: NCT05127811    
Other Study ID Numbers: d5ZTCN100
First Posted: November 19, 2021    Key Record Dates
Last Update Posted: November 19, 2021
Last Verified: October 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Lymphoma
Lymphoma, Non-Hodgkin
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases