Status:
RECRUITING
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)
Lead Sponsor:
AbbVie
Conditions:
Hepatocellular Carcinoma (HCC)
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
Hepatocellular carcinoma (HCC) is a common cancer worldwide and a leading cause of cancer-related death. The majority of participants first presenting with HCC have advanced unresectable or metastatic...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 11 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2027
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT06487559
Start Date
September 11 2024
End Date
October 1 2027
Last Update
March 4 2025
Active Locations (11)
Enter a location and click search to find clinical trials sorted by distance.
1
Beijing Youan Hospital, Capital Medical University -No differernce with previous /ID# 261928
Beijing, Beijing Municipality, China, 100069
2
Mengchao Hepatobiliary Hospital of Fujian Medical University /ID# 262443
Fuzhou, Fujian, China, 350012
3
Sun Yat-Sen University Cancer Center /ID# 262092
Guangzhou, Guangdong, China, 510060
4
Nanfang Hospital of Southern Medical University /ID# 262091
Guangzhou, Guangdong, China, 510515