A Study to Assess the Adverse Events and How Intravenously Infused Livmoniplimab in Combination With Budigalimab Moves Through the Bodies of Adult Chinese Participants With Locally Advanced or Metastatic Hepatocellular Carcinoma (HCC)

Launched by ABBVIE · Jun 28, 2024

Keywords

ClinConnect Summary

This clinical trial is testing a new treatment for adult patients in China who have a type of liver cancer called hepatocellular carcinoma (HCC). Specifically, the study is looking at how safe and effective two investigational drugs, livmoniplimab and budigalimab, are when given together. The trial has two parts: the first part will gradually increase the dose of livmoniplimab combined with a fixed dose of budigalimab, while the second part will give participants multiple doses of both drugs. The goal is to find out how these medications work in the body and any side effects they may cause.

To participate in this trial, individuals must be adults diagnosed with locally advanced or metastatic HCC, and they should have a good level of overall health. This means they should have no serious health conditions that would interfere with their ability to join the study. Participants can expect to visit a hospital or clinic regularly for treatments, check-ups, blood tests, and scans for up to two years. While this study may require more visits and monitoring than standard treatment, it could provide valuable information about a new option for managing HCC.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Locally advanced or metastatic and/or unresectable HCC
• • Child-Pugh A
• • Barcelona Clinic Liver Cancer stage B or C
• • Eastern Cooperative Oncology Group (ECOG) Perfromance Status of 0-1
• • Received an immune checkpoint inhibitor in 1L HCC treatment regimen
• • Adequate hematologic and end-organ function
• Exclusion Criteria:
• • Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases as outlined in the protocol.
• • History of malignancy other than HCC within 5 years prior to screening, except for malignancies with a negligible risk of metastasis or death (e.g., 5-year OS rate \> 90%).
• • History of autoimmune, immune deficiency, or inflammatory disorders including, but not limited to, inflammatory bowel disease, systemic lupus erythematosus, sarcoidosis, Wegener syndrome, rheumatoid arthritis, antiphospholipid antibody syndrome, Guillain-Barre syndrome, or multiple sclerosis
• • History of clinically significant conditions such as but not limited to the following: renal, neurologic, psychiatric, endocrine, metabolic, immunologic, cardiovascular, pulmonary, or hepatic disease within the last 6 months that in Investigator's opinion, would adversely affect the subject's participation in the study.