Delcath Systems (DCTH) said Monday it has received US Food and Drug Administration clearance to begin patient enrollment for a phase 2 clinical trial evaluating Hepzato in combination with standard of care for liver-dominant metastatic breast cancer.
The trial will assess the safety and efficacy of this combination therapy, aiming to offer a new treatment option for patients with limited alternatives, the company said, adding that about 90 patients will be enrolled across more than 20 sites in the US and Europe, with enrollment starting in Q4.
The trial's primary endpoint, hepatic progression-free survival, is expected by the end of 2028, with overall survival results, a secondary endpoint, anticipated in 2029, Delcath said.
Shares of Delcath were down 1.7% in recent Monday trading.
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