Azenosertib + Carboplatin + Pembrolizumab for Breast Cancer
Trial Summary
Do I need to stop my current medications to join the trial?
The trial requires that you stop any prior cytotoxic chemotherapy and biologic therapy at least 14 days before starting the study treatment. Additionally, you must not take any medications that are strong or moderate inhibitors or inducers of certain liver enzymes (CYP3A4/CYP3A5) and P-gp inhibitors, and these should be stopped before the trial as specified. Please consult with the trial team for specific guidance on your current medications.
What data supports the effectiveness of the drug combination Azenosertib, Carboplatin, and Pembrolizumab for breast cancer?
Is the combination of Azenosertib, Carboplatin, and Pembrolizumab safe for humans?
Pembrolizumab, one of the drugs in the combination, has been used in various cancer treatments and is generally considered safe, but it can cause side effects like pneumonitis (lung inflammation) in 1%-5% of patients. Safety data for the specific combination with Azenosertib and Carboplatin is not available, but pembrolizumab has been studied extensively in combination with other drugs.678910
What makes the drug combination of Azenosertib, Carboplatin, and Pembrolizumab unique for breast cancer treatment?
This drug combination is unique because it combines Azenosertib, a novel agent, with Carboplatin, a chemotherapy drug, and Pembrolizumab, an immunotherapy, to target breast cancer in multiple ways, potentially enhancing effectiveness, especially in BRCA-related cases that are sensitive to DNA-damage agents.1271112
What is the purpose of this trial?
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)
Research Team
Filipa Lynce, MD
Principal Investigator
Dana-Farber Cancer Institute
Eligibility Criteria
This trial is for patients with metastatic triple-negative breast cancer. Participants should meet specific health criteria not detailed here.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Phase 1: Dose Escalation
Participants are enrolled in a 3+3 dose-escalation scheme to establish the Maximum Tolerated Dose (MTD) of Azenosertib
Phase 2: Treatment
Participants receive Azenosertib, Carboplatin, and Pembrolizumab with regular CT or MRI scans and tumor biopsies
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Azenosertib
- Carboplatin
- Pembrolizumab
Find a Clinic Near You
Who Is Running the Clinical Trial?
Filipa Lynce, MD
Lead Sponsor
Zentalis Pharmaceuticals
Collaborator
Merck Sharp & Dohme LLC
Industry Sponsor
Chirfi Guindo
Merck Sharp & Dohme LLC
Chief Marketing Officer since 2022
Degree in Engineering from Ecole Centrale de Paris, MBA from New York University Stern School of Business
Robert M. Davis
Merck Sharp & Dohme LLC
Chief Executive Officer since 2021
JD from Northwestern University Pritzker School of Law, MBA from Northwestern University Kellogg Graduate School of Management, Bachelor's in Finance from Miami University