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Spots Global Cancer Trial Database for A Study of ZN-c3 in Participants With Solid Tumors

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Trial Identification

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

Conditions

Solid Tumor

Interventions

ZN-c3

Study Description

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.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

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

Contact Details

Name: Philippe Pultar, MD

Affiliation: K-Group Beta, a Zentalis Company

Role: STUDY_DIRECTOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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