Clinical Trials
0
0 active
Approvals
2
Total approvals
Agencies
1
Regulatory bodies
Founded
1987
No trial phase data available
No trial data available
No trial data available
- A phase 3 clinical trial led by Moffitt Cancer Center demonstrates that the melphalan hepatic delivery system significantly improves progression-free survival in patients with metastatic uveal melanoma to 9.1 months versus 3.3 months with standard care. - The novel treatment approach delivers high-dose chemotherapy directly to the liver while filtering the drug before it reaches the rest of the body, resulting in an 80% disease control rate compared to 46.9% with conventional therapies. - The FDA approved this liver-directed therapy in August 2023 based on the FOCUS trial results, offering new hope for patients with this rare eye cancer that has historically been difficult to treat and associated with poor outcomes.
- Delcath Systems received FDA clearance for its IND application to initiate a Phase 2 trial of Hepzato Kit in liver-dominant metastatic colorectal cancer (mCRC). - The trial will evaluate Hepzato Kit combined with trifluridine-tipiracil and bevacizumab against the standard of care alone, enrolling 90 patients across US and Europe. - Hepatic progression-free survival (hPFS) is the primary endpoint, with results expected by the end of 2027, and overall survival (OS) data anticipated in 2028. - Hepzato Kit, combining melphalan with a hepatic delivery system, aims to improve tumor response while minimizing hepatotoxicity and systemic exposure.
