A Phase I/II Single-arm Trial of Azenosertib (ZN-c3) Combined With

Status Not yet recruiting

Clinical Trial Summary

This research is being done to evaluate the safety and effectiveness of a drug currently known as Azenosertib (ZN-C3) in combination with the drugs carboplatin and pembrolizumab in metastatic triple-negative breast cancer. The names of the study drugs involved in this study are: - Azenosertib (a type of WEE1 inhibitor) - Carboplatin (a type of platinum compound) - Pembrolizumab (a type of monoclonal antibody)

Clinical Trial Description

This is a non-randomized, open-label, phase I/II study designed to evaluate the safety and efficacy of azenosertib in combination with carboplatin and pembrolizumab in participants with metastatic triple negative breast cancer (TNBC) Azenosertib is a medication that targets WEE1, an important protein in tumor growth. The U.S. Food and Drug Administration (FDA) has not approved azenosertib as a treatment for metastatic triple-negative breast cancer. The FDA has approved carboplatin as a treatment option for metastatic triple-negative breast cancer and it is considered standard of care for breast cancer. The FDA has approved pembrolizumab for metastatic triple-negative breast cancer, but it is currently approved only for PD-L1 positive cancer. The research study procedures include screening for eligibility, study treatment visits, blood tests, Computerized Tomography (CT) scans, Magnetic Resonance Imaging (MRI) scans, electrocardiograms (EKGs), and tumor biopsies in Phase 2. It is expected that about 12-18 people will take part in the phase 1 portion and 60 people for the phase 2 portion of this research study. Zentalis Pharmaceuticals is funding this research study and providing Azenosertib. Merck is supporting this research study by providing pembrolizumab. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT06351332
Study type	Interventional
Source	Dana-Farber Cancer Institute
Contact	Filipa Lynce, MD
Phone	617-632-3800
Email	filipa_lynce@dfci.harvard.edu
Status	Not yet recruiting
Phase	Phase 1/Phase 2
Start date	September 2024
Completion date	September 1, 2029

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

A Phase I/II Single-arm Trial of Azenosertib (ZN-c3) Combined With Carboplatin and Pembrolizumab in Patients With Metastatic Triple-negative Breast Cancer (ZAP-IT)

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms