Delcath Systems (NASDAQ: DCTH) has announced that the first patient has been dosed at the European Institute of Oncology (IEO) in Milan, Italy, in its global Phase 2 clinical trial evaluating HEPZATO in combination with standard of care treatment for liver-dominant metastatic breast cancer (mBC).
Approximately 90 patients will be enrolled in this randomized, controlled trial, which is expected to be conducted at more than 20 sites across the U.S. and Europe.
In a statement, Gerard Michel, CEO of Delcath, commented, “Dosing the first patient in this Phase 2 trial at the IEO in Milan, Italy is an important milestone in our effort to expand the clinical investigation of HEPZATO into liver-dominant metastatic breast cancer. Building on encouraging efficacy signals in real-world evidence presented at ESMO Breast Cancer 2026 and our commercial success in metastatic uveal melanoma, we’re strengthening how we engage sites, educate physicians on liver-directed therapy, and identify appropriate patients. We are encouraged by the momentum we are seeing and look forward to advancing our evaluation of HEPZATO’s potential to address significant unmet needs in oncology beyond metastatic uveal melanoma.”
