Title: Phase 1b study of EZH1/2 inhibitor valemetostat in combination with trastuzumab deruxtecan in subjects with HER2 low/ultra-low/null metastatic breast cancer
Principal Investigator: Senthil Damodaran, MD, PhD, of MD Anderson Cancer Center in Houston, Texas
Description: Researchers are conducting a phase 1b trial to test the safety and efficacy of valemetostat in combination with trastuzumab deruxtecan in patients with HER2-low/ultra-low/null metastatic breast cancer.
The study has dose-escalation and dose-expansion phases. In the dose-escalation phase, patients in the first arm will receive trastuzumab deruxtecan on a fixed dosing schedule and valemetostat at escalating doses. In the second arm, patients will receive 1 dose level of valemetostat.
The primary outcomes are safety and the maximum tolerated dose/recommended dose for expansion in the first part of the study, and objective response rate in the dose-expansion part of the study. Secondary outcomes include the objective response rate in the dose-escalation phase and survival outcomes in both phases, among other endpoints.
To be eligible for this study, patients must be 18 years of age or older. They must have metastatic or locally advanced HER2-low/ultra-low/null breast cancer that is not eligible for resection. For a complete list of eligibility criteria, please see the reference.
This study is sponsored by MD Anderson Cancer Center in collaboration with Daiichi Sankyo, Inc.
ClinicalTrials.gov. Phase 1b study of EZH1/2 inhibitor valemetostat in combination with trastuzumab deruxtecan in subjects with HER2 low/ultra-low/null metastatic breast cancer. NCT05633979. Accessed March 17, 2023.