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

Sponsor

Zentera Therapeutics HK Limited (Industry)

Overall Status

Enrolling by invitation

CT.gov ID

NCT05127811

Collaborator

(none)

Enrollment

Locations

Arms

28.6

Anticipated Duration (Months)

Patients Per Site

0.3

Patients Per Site Per Month

Study Details

Study Description

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.

Study Design

Study Type:

Interventional

Anticipated 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 :

Oct 21, 2021

Anticipated Primary Completion Date :

May 23, 2023

Anticipated Study Completion Date :

Mar 9, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 100mg(on empty)	Drug: ZN-d5 BION design
Experimental: 200mg(on empty)	Drug: ZN-d5 BION design
Experimental: 400mg(on empty)	Drug: ZN-d5 BION design
Experimental: 600mg(on empty)	Drug: ZN-d5 BION design
Experimental: 600mg（with a meal）	Drug: ZN-d5 BION design
Experimental: 800mg(with a meal)	Drug: ZN-d5 BION design

Outcome Measures

Primary Outcome Measures

Safety monitoring [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 [at the end of Cycle 1]
Dose-limiting toxicities (DLTs) observed in DLT evaluable subjects

Secondary Outcome Measures

Effacy Evaluation [up to 24 months]
Efficacy as defined by the 2014 Lugano response criteria
Maximum Plasma Concentration [Cmax] [up to 24 months]
Plasma PK parameters of ZN-d5

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	BeiJing Cancer Hospital	BeiJing	Beijing	China	100142
2	Sun Yan Set University Cancer Center	Guangzhou	Guangdong	China
3	Fudan University Shanghai Cancer Hospital	Shanghai	Shanghai	China

Sponsors and Collaborators

Zentera Therapeutics HK Limited

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Zentera Therapeutics HK Limited

ClinicalTrials.gov Identifier:

NCT05127811

Other Study ID Numbers:

d5ZTCN100

First Posted:

Nov 19, 2021

Last Update Posted:

May 16, 2022

Last Verified:

May 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Yes

Additional relevant MeSH terms:

Lymphoma

Lymphoma, Non-Hodgkin

Study Results

No Results Posted as of May 16, 2022