10:17 AM EST, 12/02/2024 (MT Newswires) -- Delcath Systems ( DCTH ) said Monday that the US Food and Drug Administration cleared its investigational new drug application for a phase 2 clinical trial of Hapzato, in combination with standard of care, in liver-dominant metastatic colorectal cancer.

The trial will evaluate the safety and efficacy of the combination therapy, with a primary endpoint of hepatic progression-free survival that is expected to be read out by the end of 2027, according to the company.

Delcath Systems ( DCTH ) said it expects to enroll about 90 patients for the study and plans to start enrollment in the second half of 2025.

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