A Study of ZN-c3 in Participants With Solid Tumors
About the study
This is a Phase 1 open-label, multicenter study of ZN-c3 monotherapy which consists of Dose Escalation, a Food Effect Cohort, and Dose Expansion.
Who can take part
You may be eligible to participate in the study if you meet the following criteria:
INCLUSION CRITERIA
- Age ≥ 18 years or the minimum legal adult age (whichever is greater) at the time of informed consent.
- Eastern Cooperative Oncology Group (ECOG) performance status ≤2.
- Adequate hematologic and organ function.
- Female subjects of childbearing potential and male subjects must agree to use an effective method of contraception and for 6 months and 90 days, respectively, after the last dose of ZN-c3.
Dose Escalation Inclusion Criteria:
- 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.
Food Effect Cohort Inclusion Criteria:
- Subjects 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.
- Subjects must have no relevant dietary restrictions, and be willing to consume a high-calorie, high-fat breakfast and other standard meals provided during the study.
Dose Expansion Inclusion Criteria:
- Measurable disease, defined as at least one lesion that can be accurately measured per RECIST version 1.1 criteria.
- Recurrent or persistent USC or locally advanced or metastatic malignancy with one or more relevant biomarkers related to deoxyribonucleic acid (DNA) damage pathways.
EXCLUSION CRITERIA
Major Exclusion Criteria:
- Prior therapy with ZN-c3 or known hypersensitivity to any drugs similar to ZN-c3 in class or any inactive ingredients present in ZN-c3.
- Prior therapy with a WEE1 inhibitor.
- A serious illness or medical condition(s).
- Unresolved toxicity of Grade >1 attributed to any prior therapies (excluding Grade ≤2 neuropathy, alopecia or skin pigmentation).
- 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 C1D1.
- Subjects with active (uncontrolled, metastatic) second malignancies or requiring therapy.
- 12-lead ECG demonstrating a corrected QT interval using Fridericia's formula (QTcF) of >480 ms, 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 or family history of long QT syndrome or Torsade de Pointes (TdP).
Study Locations
Enter your ZIP code/Postal code/PIN code to locate study sites near you:
How to Apply
Contact the study center to learn if this study is a good match for you.
Study Details
Contition
Solid Tumor
Age
18+
Phase
PHASE1
Participants Needed
146
Est. Completion Date
Aug 31, 2023
Treatment Type
INTERVENTIONAL
Sponsor
K-Group, Beta, Inc., a wholly owned subsidiary of Zentalis Pharmaceuticals, Inc
ClinicalTrials.gov NCT Identifier
NCT04158336
Study Number
ZN-c3-001
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