Ignite Creation Date:
2025-12-24 @ 9:59 PM
Ignite Modification Date:
2025-12-25 @ 7:36 PM
Study NCT ID:
NCT06351332
Status:
RECRUITING
Last Update Posted:
2024-12-18
First Post:
2024-04-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
ZAP-IT: ZN-c3 + Carboplatin + Pembrolizumab in MTNBC
Sponsor:
Filipa Lynce, MD
Organization:
Study Overview
Official Title:
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:
RECRUITING
Status Verified Date:
2024-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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)
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.
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: