Delcath Commences DELUMA Trial of Hepzato in Liver-Dominant Metastatic Breast Cancer

July 14, 2026—Delcath Systems, Inc., an interventional oncology company focused on the treatment of primary and metastatic liver cancers, announced that the first patient has been dosed at the European Institute of Oncology in Milan, Italy, in a global phase 2 clinical trial evaluating the company’s Hepzato in combination with standard of care (SOC) treatment for liver-dominant metastatic breast cancer (mBC).

According to Delcath, the phase 2 DELUMA trial will evaluate the safety and efficacy of Hepzato in combination with SOC versus SOC alone in patients with liver-dominant HER2-negative mBC following the failure of previous treatments. The SOC options will be the physician’s choice of eribulin, vinorelbine, or capecitabine.

As noted in the company’s press release, the randomized controlled trial will enroll approximately 90 patients and is expected to be conducted at > 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.

In the United States, Hepzato Kit is considered a combination drug and device product and is regulated and approved for sale as a drug by the FDA.

Hepzato Kit is comprised of the chemotherapeutic drug melphalan and Delcath’s hepatic delivery system (HDS), which is used to isolate the liver from general circulation, allowing for the delivery of high-dose melphalan directly to the liver while limiting systemic exposure.

Delcath advised that in the United States, the Hepzato Kit is approved as a liver-directed treatment for adult patients with metastatic uveal melanoma with unresectable hepatic metastases affecting < 50% of the liver and no extrahepatic disease, or extrahepatic disease limited to the bone, lymph nodes, subcutaneous tissues, or lung that is amenable to resection or radiation.

In Europe, the device-only configuration of the HDS is regulated as a class III medical device and is approved for sale under the trade name Chemosat and is used to treat a wide range of liver cancers, stated the company.