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 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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