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Brief Title: A Study of ZN-c3 in Participants With Solid Tumors
Official Title: A Phase 1 Study of ZN-c3 as a Single Agent in Subjects With Solid Tumors
Study ID: NCT04158336
Brief Summary: 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.
Detailed Description: This study will evaluate the safety, tolerability, efficacy, pharmacokinetics (PK) and pharmacodynamics of ZN-c3. In Dose Escalation, the study will identify the Maximum Tolerated Dose (MTD) of ZN-c3 monotherapy in solid tumors. The Food Effect cohort sub-study will examine ZN-c3 PK after a single dose and determine the bioavailability of ZN-c3 under fed and fasted conditions. In Dose Expansion, single agent ZN-c3 will be evaluated at the RP2D in subjects with recurrent or persistent uterine serous carcinoma (USC) or subjects with locally advanced or metastatic solid tumor malignancies harboring biomarkers related to deoxyribonucleic acid (DNA) damage pathways.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Site 0102, Tucson, Arizona, United States
Site 0167, Newport Beach, California, United States
Site 0171, Chicago, Illinois, United States
Site 0101, Detroit, Michigan, United States
Site 0173, New York, New York, United States
Site 0179, Pittsburgh, Pennsylvania, United States
Site 0103, Houston, Texas, United States
Site 0100, San Antonio, Texas, United States
Name: Philippe Pultar, MD
Affiliation: K-Group Beta, a Zentalis Company
Role: STUDY_DIRECTOR