A Study to Evaluate ALN-BCAT in Patients With Hepatocellular Carcinoma

Launched by ALNYLAM PHARMACEUTICALS · Sep 13, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called ALN-BCAT for people with advanced liver cancer, specifically a type known as hepatocellular carcinoma (HCC). The trial has two main parts: the first part is figuring out how safe ALN-BCAT is when given alone or together with another drug called pembrolizumab, and finding the best dose to use. The second part looks at how well ALN-BCAT works in fighting the cancer when used alone or with pembrolizumab, while also checking for any side effects.

To participate in this trial, you need to have a confirmed diagnosis of HCC and have already tried at least one treatment for your cancer. You should also have a specific type of genetic change related to your cancer. The trial is open to adults aged 65 and older, and both men and women can join. If you qualify and choose to participate, you can expect to receive the study drug and be closely monitored for how well it works and any side effects that may occur. It’s important to know that there are certain conditions that might exclude you from participating, such as having specific rare forms of liver cancer or active disease outside the liver.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Has HCC confirmed histologically or cytologically, or, for patients with liver cirrhosis, clinically by the American Association for the Study of Liver Diseases (AASLD) criteria
• • Has had at least one line of systemic therapy for unresectable advanced or metastatic disease
• • Has at least one wingless-related integration site (WNT)-pathway activating mutation
• • Child-Pugh class A or B7
• Exclusion Criteria:
• • Has fibrolamellar HCC, sarcomatoid HCC, or mixed cholangio-HCC tumors
• • Has symptomatic extrahepatic disease
• • Has received anti-cancer therapy or investigational drugs ≤3 weeks prior to the first dose of study drug
• • Note: other protocol defined inclusion / exclusion criteria apply