Study on ZN-c3, Carboplatin, and Pembrolizumab for Metastatic Triple-Negative Breast Cancer

Sponsor: Filipa Lynce, MD

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT06351332

Provider View

This clinical trial is testing a new treatment combination of ZN-c3, carboplatin, and pembrolizumab to see if it is safe and effective for patients with metastatic triple-negative breast cancer.

Patient Parameters

Program Overview

The purpose of this study is to evaluate the safety and effectiveness of a new drug called Azenosertib (ZN-C3) when used with carboplatin and pembrolizumab in treating metastatic triple-negative breast cancer. Azenosertib is a type of drug that targets a protein involved in tumor growth. While carboplatin and pembrolizumab are approved for use in this type of cancer, Azenosertib is still being studied. Participants will undergo various procedures, including blood tests, scans, and biopsies, to monitor their response to the treatment. The study is funded by Zentalis Pharmaceuticals and supported by Merck.

Description

This study is divided into two phases: Phase I and Phase II. In Phase I, the focus is on determining the safety of the treatment combination, while Phase II will assess its effectiveness in shrinking tumors. Participants will receive the study drugs and undergo regular health checks, including blood tests, CT and MRI scans, and heart monitoring. The study aims to enroll about 12-18 people in Phase I and 60 people in Phase II. Participants will be closely monitored for any side effects and their overall response to the treatment. The study is sponsored by Zentalis Pharmaceuticals, with Merck providing pembrolizumab.

Eligibility Criteria

Inclusion Criteria

  • Have confirmed invasive breast cancer that is either locally advanced or has spread to other parts of the body.
  • The cancer must be triple-negative, meaning it does not have certain hormone receptors or HER2 protein.
  • Have at least one tumor that can be measured by scans and is not in an area previously treated with radiation.
  • Have received 1-3 prior chemotherapy treatments for metastatic breast cancer, including one with an antibody drug conjugate.
  • Be 18 years or older.
  • Have a performance status score of 0 to 2, indicating full activity or some restriction in strenuous activities.
  • Have normal organ and blood function as determined by specific tests.
  • Be willing to undergo tumor biopsies for research purposes.
  • Women of childbearing potential must have a negative pregnancy test and agree to use effective contraception during the study and for a period after.
  • Be able to swallow pills and understand the study requirements.
  • Have treated and stable brain metastases, if present.
  • Have no other active cancers that could interfere with the study.

Exclusion Criteria

  • Have had major surgery within 28 days before starting the study treatment.
  • Have received a prior WEE1 inhibitor.
  • Have progressed on prior platinum chemotherapy.
  • Have untreated or symptomatic brain metastases.
  • Have severe allergic reactions to similar drugs.
  • Have a history of lung disease requiring steroids.
  • Have received an investigational drug or vaccine recently.
  • Have other active cancers requiring treatment within the past 3 years.
  • Have uncontrolled medical conditions or infections.
  • Have a history of heart conditions affecting the QT interval.
  • Be pregnant or breastfeeding, or planning to conceive during the study.
  • Have had an organ transplant.

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