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.
A Study of ZN-c3 in Subjects With Malignant Tumors
A Phase 2, Multicenter Study to Evaluate Efficacy and Safety of ZN-c3 in Subjects with Malignant Tumors Harboring DNA Damage Pathway Biomarkers (ZN-c3-005 / GOG-3066).
Solid tumors
All genders
18+
Recruiting now
Overview
Principal Investigator: Sarah Paraghamian, MD
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Latoya Lashley
Study details
Inclusion Criteria
- 1. Locally advanced or metastatic malignancy with one or more relevant biomarkers related to deoxyribonucleic acid (DNA) damage pathways
- 2. 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.
- 3. Subjects must have at least one measurable lesion as defined by RECIST Guideline Version 1.1.
Exclusion Criteria
- 1. Any of the following treatment interventions within a specified time frame prior to C1D1: Major surgery within 28 days; Any chemotherapy within 14 days; Radiation therapy within 21 days; Autologous or allogeneic stem cell transplant within 3 months; Current use of any other investigational drug therapy <28 days.
- 2. Prior therapy with ZN-c3 or any other WEE1 inhibitor.
- 3. Unresolved toxicity of Grade >1 attributed to any prior therapies.
Study Requirements
Subjects will be pre-screened for relevant genetic alterations in DDR-related genes or will be considered eligible based on prior genomic profiling. Potentially eligible subjects will undergo a screening period of up to 28 days followed by 21-day continuous treatment cycles with ZN-c3 until the subject experiences PD or meets any other protocol-specified withdrawal criteria. Approximately 105 subjects will be enrolled across the two cohorts. Subjects will undergo a screening period of up to 28 days followed by 21-day continuous treatment cycles with ZN-c3 until the subject experiences PD or meets other protocol-specified withdrawal criteria. After treatment discontinuation, the subject will complete a follow-up safety evaluation 30 days after the last treatment administration.