A Phase 2 Open-Label, Multicenter Study to Evaluate Efficacy and Safety of ZN‑c3 in Subjects with Malignant Tumors Harboring DNA Repair and Cell Cycle Gene Alterations
This is a Phase 2 open-label, multicenter study to evaluate the clinical activity, safety, pharmacokinetics (PK), and biomarker profile of ZN-c3 in subjects with locally advanced or metastatic solid tumor malignancies harboring biomarkers related to deoxyribonucleic acid (DNA) damage pathways.
- Experimental: ZN-c3
- Provision of signed informed consent (obtained according to institutional guidelines) prior to initiation of any study-related procedures.
- Age ≥18 years at the time of informed consent.
- Locally advanced or metastatic malignancy with one or more relevant biomarkers related to deoxyribonucleic acid (DNA) damage pathways
- Subjects must have received prior standard therapy appropriate for their tumor type and stage of disease, or in the opinion of the Investigator, would be unlikely to tolerate or derive clinically meaningful benefit from appropriate standard of care therapy, or no standard therapy exists for their tumor type/stage. Prior treatment with immune checkpoint inhibitors is allowed.
- Subjects must have at least one measurable lesion as defined by RECIST Guideline Version 1.1.
- Performance Status: Eastern Cooperative Oncology Group (ECOG) score of ≤2.
- Adequate hematologic and organ function
- Willingness and ability to release archival tissue
- Females of childbearing potential and male subjects must agree to use an effective method of contraception 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.