NCT06351332

ZAP-IT: ZN-c3 + Carboplatin + Pembrolizumab in mTNBC

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)

• Status: Active Not Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 78 (estimated)
• Sponsor: Filipa Lynce, MD · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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)

Detailed 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.

Conditions

• Breast Cancer
• Breast Cancer Female
• Triple Negative Breast Cancer
• Hormone Receptor Negative Malignant Tumor Breast Triple
• HER2-negative Breast Cancer

Interventions

Type	Name	Description
DRUG	Azenosertib	WEE1 inhibitor, 25 or 100 mg tablet, taken orally per protocol.
DRUG	Carboplatin	Platinum coordination compound, 5-, 15-, 45-, and 60-mL vials, via intravenous (into the vein) infusion per institutional standards.
DRUG	Pembrolizumab	Humanized immunoglobulin G4 monoclonal antibody, 4-mL vials, via intravenous (into the vein) infusion per protocol.

Timeline

• Start date: 2024-05-01
• Primary completion: 2027-03-01
• Completion: 2029-09-01
• First posted: 2024-04-08
• Last updated: 2026-01-12

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study