RecruitingPhase 1NCT05422794

Testing the Addition of Anti-Cancer Drug, ZEN003694 (ZEN-3694) and PD-1 Inhibitor (Pembrolizumab), to Standard Chemotherapy (Nab-Paclitaxel) Treatment in Patients With Advanced Triple-Negative Breast Cancer

A Phase 1b Trial of ZEN003694 (ZEN-3694) With Pembrolizumab and Nab-Paclitaxel in Patients With Metastatic Triple-Negative Breast Cancer


Sponsor

National Cancer Institute (NCI)

Enrollment

57 participants

Start Date

May 18, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

This phase Ib trial tests the safety and tolerability of ZEN003694 in combination with an immunotherapy drug called pembrolizumab and the usual chemotherapy approach with nab-paclitaxel for the treatment of patients with triple negative-negative breast cancer that has spread to other parts of the body (advanced). Paclitaxel is in a class of medications called antimicrotubule agents. It stops cancer cells from growing and dividing and may kill them. Nab-paclitaxel is an albumin-stabilized nanoparticle formulation of paclitaxel which may have fewer side effects and work better than other forms of paclitaxel. Immunotherapy with monoclonal antibodies, such as pembrolizumab may help the body's immune system attach the cancer and may interfere with the ability of tumor cells to grow and spread. ZEN003694 is an inhibitor of a family of proteins called the bromodomain and extra-terminal (BET). It may prevent the growth of tumor cells that over produce BET protein. Combination therapy with ZEN003694 pembrolizumab immunotherapy and nab-paclitaxel chemotherapy may help shrink or stabilize cancer for longer than chemotherapy alone.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether adding two targeted drugs — ZEN-3694 (a BET inhibitor) and pembrolizumab (an immunotherapy) — to standard chemotherapy (nab-paclitaxel) improves outcomes for patients with advanced triple-negative breast cancer (TNBC), a particularly aggressive form of breast cancer. **You may be eligible if:** - You have been diagnosed with triple-negative breast cancer (ER-negative, PR-negative, HER2-negative) - Your cancer is locally advanced (cannot be removed) or has spread to other parts of the body - You are at least 18 years old - Your cancer is measurable on scans - Your general health and organ function are adequate **You may NOT be eligible if:** - Your cancer is not triple-negative (i.e., hormone receptor-positive or HER2-positive) - Your ER, PR, and HER2 status is unknown - You have certain uncontrolled medical conditions - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGBET Bromodomain Inhibitor ZEN-3694

Given PO

PROCEDUREBiopsy Procedure

Undergo biopsy

PROCEDUREBiospecimen Collection

Undergo collection of blood samples

PROCEDUREComputed Tomography

Undergo CT

PROCEDUREMagnetic Resonance Imaging

Undergo MRI

DRUGNab-paclitaxel

Given IV

BIOLOGICALPembrolizumab

Given IV


Locations(6)

Boston Medical Center

Boston, Massachusetts, United States

Dana-Farber Cancer Institute

Boston, Massachusetts, United States

NYU Langone Hospital - Long Island

Mineola, New York, United States

Laura and Isaac Perlmutter Cancer Center at NYU Langone

New York, New York, United States

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, United States

Vanderbilt Breast Center at One Hundred Oaks

Nashville, Tennessee, United States

View Full Details on ClinicalTrials.gov

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NCT05422794


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