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

NCT05127811 | Terminated Phase 1 FDA Drug

• 1 other identifier: d5ZTCN100
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 3

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).

Conditions

Non-Hodgkin Lymphoma

Outcome Measures

Primary Outcomes (2)

• 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

  until 30 days after the last dose of study drug

• DLT

  Dose-limiting toxicities (DLTs) observed in DLT evaluable subjects

  at the end of Cycle 1

Secondary Outcomes (2)

• Effacy Evaluation

  up to 24 months

• Maximum Plasma Concentration [Cmax]

  up to 24 months

Study Arms (6)

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

Interventions

ZN-d5 DRUG

BION design

100mg(on empty); 200mg(on empty); 400mg(on empty); 600mg(on empty); 600mg（with a meal）; 800mg(with a meal)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).
• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Zentera Therapeutics HK Limited: lead

Study Sites (3)

BeiJing Cancer Hospital

Beijing, Beijing Municipality, 100142, China

Location

Sun Yan Set University Cancer Center

Guangzhou, Guangdong, China

Location

Fudan University Shanghai Cancer Hospital

Shanghai, Shanghai Municipality, China

Location

MeSH Terms

Conditions

Lymphoma, Non-Hodgkin

Condition Hierarchy (Ancestors)

Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 18, 2021
• First Posted: November 19, 2021
• Study Start: October 21, 2021
• Primary Completion: May 26, 2023
• Study Completion: May 26, 2023
• Last Updated: June 2, 2023

Record last verified: 2023-05

Locations

CN (3)