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This is a Phase 1b open-label, multicenter study, evaluating the safety, tolerability, efficacy, pharmacokinetics (PK) and pharmacodynamics of ZN c3.
This study consists of Dose Escalation and Dose Expansion component in Chinese subjects with solid tumors, described briefly as follows:
Dose Escalation: Single Agent Dose Escalation of ZN-c3 in solid tumors.
Dose Expansion: Single Agent ZN-c3 in solid tumors at the RP2D dose level.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single Agent Dose Escalation | Experimental | Participants with solid tumors with advanced or metastatic disease who are refractory or ineligible to standard therapy(ies) or for whom no standard therapy is available. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ZN-c3 | Drug | ZN-c3 is a study drug |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Incidence and severity of dose-limiting toxicities (DLTs) in DLT evaluable subjects during Cycle 1 | At the end of Cycle 1 (each cycle is 21 days) |
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Inclusion Criteria:
Provision of written informed consent prior to initiation of any study-related procedures that are not considered standard of care.
Age ≥ 18 years or the minimum legal adult age (whichever is greater) at the time of informed consent.
Adequate hematologic and organ function as defined by the following criteria:
Female subjects of childbearing potential must have a negative serum beta human chorionic gonadotropin test.
Male subjects and female subjects of childbearing potential must agree to use an effective method of contraception per institutional standard prior to the first dose and for 90 days after the last dose of ZN-c3.
Willingness and ability to comply with scheduled visits, treatment plan, laboratory tests and other study procedures.
Willingness to practice adequate sun protection (use of sunscreen or sun-protective clothing or limitation of sun exposure).
Eastern Cooperative Oncology Group (ECOG) performance status ≤1
Subjects must have a solid tumor with advanced or metastatic disease, refractory to standard therapy or for whom no standard therapy is available, or the subject is ineligible for standard therapy(ies).
Measurable or evaluable disease per RECIST version 1.1.
Subjects with advanced or metastatic disease, refractory to standard therapy or for whom no standard therapy is available, or the subject is ineligible for standard therapy(ies).
Exclusion Criteria:
Any of the following treatment interventions within the specified time frame prior to Cycle 1 Day 1:
A serious illness or medical condition(s) including, but not limited to, the following:
Unresolved toxicity of Grade > 1 attributed to any prior therapies (excluding Grade 2 neuropathy, alopecia or skin pigmentation).
Prior therapy with ZN-c3 or known hypersensitivity to any drugs similar to ZN c3 in class.
Prior therapy with a WEE1 inhibitor.
Pregnant or lactating females (including the cessation of lactation) or females of childbearing potential who have a positive serum pregnancy test within 14 days prior to Cycle 1 Day 1.
Subjects with active (uncontrolled, metastatic) second malignancies or requiring therapy.
Individuals who are judged by the Investigator to be unsuitable as study subjects.
12-lead ECG demonstrating a corrected QT interval using Fridericia's formula (QTcF) of > 450 msec, except for subjects with atrioventricular pacemakers or other conditions (e.g., right bundle branch block) that render the QT measurement invalid.
History or current evidence of congenital long QT syndrome.
Administration of strong and moderate CYP3A4 inhibitors and inducers as well as strong and moderate P-gp inhibitors.
Patients with active HBV and HCV infection: HBV DNA is higher than the upper limit of reference value if anti-HBC positive, HCV virus copy number exceeds the lower limit of detection method.
A known history of human immunodeficiency virus infection or serum anti-HIV positive.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xu Li, M.Sc | Contact | +86 15902153353 | xli@zenteratx.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fudan University Zhongshan Hospital | Recruiting | Shanghai | Shanghai Municipality | 200000 | China |
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| ID | Term |
|---|---|
| D004341 | Drug Evaluation |
| ID | Term |
|---|---|
| D000076722 | Drug Development |
| D008919 | Investigative Techniques |
| D005069 | Evaluation Studies as Topic |
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| Sichuan University Huaxi Hospital | Recruiting | Chengdu | Sichuan | China |
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| Sir Run Run Shaw Hospital | Recruiting | Hangzhou | Zhejiang | China |
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