Delcath System has received clearance from the US Food and Drug Administration (FDA) for an investigational new drug (IND) application to start enrolment in a Phase II trial evaluating its Hepzato Kit (melphalan/hepatic delivery system) as an add-on treatment in patients with liver-dominant metastatic colorectal cancer (mCRC).
The open-label randomised study (NCT06607458) is expected to enrol 90 participants across 20 sites in the US and Europe. The patient enrolment is expected to start in the second half of 2025.
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The Phase II trial will compare the efficacy and safety of the Hepazo kit when used in combination with the standard of care, trifluridine-tipiracil chemotherapy with Roche’s Avastin (bevacizumab), with the standard of care alone. The study’s primary endpoint is hepatic progression-free survival (hPFS), and results are expected to be read out by the end of 2027. The trial’s secondary endpoint includes overall survival (OS), progression-free survival (PFS), overall response rate (ORR) and hepatic ORR, which are anticipated to be read out in 2028.
The Hepzato Kit combines the chemotherapy drug melphalan with Delcath’s proprietary hepatic delivery system (HDS), which isolates and filters hepatic venous blood from the systemic circulation during melphalan infusion. The drug-device combo is designed to potentially induce a clinically meaningful tumour response with minimal hepatotoxicity and reduce systemic exposure.
The kit is approved by the FDA for treating the extra-ocular metastases of uveal melanoma, which affect either up to 50% of the liver tissue without extrahepatic disease, or metastases limited to extrahepatic organs namely bone, lymph nodes, subcutaneous tissue, or lung. The kit has been approved in Europe since 2012 and is marketed as the Chemosat hepatic delivery system for liver cancers.
Delcath plans to expand indications for the Hepzato Kit to include cholangiocarcinoma and other primary and metastatic liver cancers. In August, the company reported positive data from an independent study showing that the Hepzato Kit offers superior liver disease control and PFS in patients with metastatic uveal melanoma with liver metastases.
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