On July 9, 2026 Delcath Systems, Inc. (Nasdaq: DCTH), an interventional oncology company focused on the treatment of primary and metastatic liver cancers, reported 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 (SOC) treatment for liver-dominant metastatic breast cancer (mBC).
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The Phase 2 trial (DELUMA; NCT06875128) will evaluate the safety and efficacy of HEPZATO in combination with standard of care (SOC) versus SOC alone in patients with liver-dominant HER2-negative mBC following the failure of previous treatments. The SOC options will be physician’s choice of eribulin, vinorelbine or capecitabine. Approximately 90 patients will be enrolled in this randomized, controlled trial, which is expected to be conducted at more than 20 sites across the United States and Europe. The trial’s primary endpoint is hepatic progression-free survival, with several secondary endpoints, including progression-free survival, overall response rate, disease control rate and overall survival.
Company management estimates that approximately 7,000 patients annually in the United States are affected by HER2-negative metastatic breast cancer with liver metastases and are candidates for third-line treatment. This population includes patients with a significant burden of liver metastases, which are likely to be the primary cause of mortality. Delcath aims to provide a novel treatment option for these patients, who have limited therapeutic alternatives.
"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," said Gerard Michel, Chief Executive Officer of Delcath Systems, Inc. "Building on encouraging efficacy signals in real-world evidence presented at ESMO (Free ESMO Whitepaper) 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."
(Press release, Delcath Systems, JUL 9, 2026, View Source [SID1234669124])