Actively 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)
Led by AbbVie · Updated on 2025-03-04
20
Participants Needed
11
Research Sites
159 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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 disease. The purpose of this study is to assess adverse events and how livmoniplimab in combination with budigalimab moves through the body in adult Chinese participants with Locally Advanced or metastatic Child-Pugh A Hepatocellular Carcinoma (HCC). Livmoniplimab is an investigational drug being developed for the treatment of HCC. There are 2 stages to this study. Stage 1 is a safety run-in. There are 2 treatment arms in stage 1 and participants will receive escalating doses of Livmoniplimab in combination with budigalimab (fixed dose). Stage 2 is dose expansion. There are 2 treatment arms in stage 2 and participants will receive Livmoniplimab in combination with budigalimab in multiple doses. Approximately 20 adult participants will be enrolled in the study across 15 sites in China. In part 1 (dose escalation), participants will be intravenously infused with escalating doses of livmoniplimab in combination with budigalimab every 3 weeks. In part 2 (dose expansion), participants will be intravenously infused with livmoniplimab in combination with budigalimab in multiple doses every 3 weeks. The estimated duration of the study is up to 2 years. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic and may require frequent medical assessments, blood tests, and scans.
CONDITIONS
Official Title
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)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults with locally advanced or metastatic and/or unresectable hepatocellular carcinoma (HCC)
- Child-Pugh A liver function classification
- Barcelona Clinic Liver Cancer stage B or C
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
- Received an immune checkpoint inhibitor in first-line HCC treatment
- Adequate blood counts and organ function
You will not qualify if you...
- Untreated, symptomatic, or actively worsening central nervous system metastases
- History of other cancers within 5 years except those with very low risk of spread or death
- History of autoimmune, immune deficiency, or inflammatory disorders such as lupus, rheumatoid arthritis, or multiple sclerosis
- Clinically significant kidney, nerve, psychiatric, hormone, metabolic, immune, heart, lung, or liver disease within the last 6 months that may interfere with study participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 11 locations
1
Beijing Youan Hospital, Capital Medical University -No differernce with previous /ID# 261928
Beijing, Beijing Municipality, China, 100069
Actively Recruiting
2
Mengchao Hepatobiliary Hospital of Fujian Medical University /ID# 262443
Fuzhou, Fujian, China, 350012
Actively Recruiting
3
Sun Yat-Sen University Cancer Center /ID# 262092
Guangzhou, Guangdong, China, 510060
Actively Recruiting
4
Nanfang Hospital of Southern Medical University /ID# 262091
Guangzhou, Guangdong, China, 510515
Actively Recruiting
5
Harbin Medical University Cancer Hospital /Id# 262070
Harbin, Heilongjiang, China, 150081
Actively Recruiting
6
Henan Cancer Hospital /ID# 262098
Zhengzhou, Henan, China, 450008
Actively Recruiting
7
Hubei Cancer Hospital /ID# 262030
Wuhan, Hubei, China, 430079
Actively Recruiting
8
The Second Affiliated Hospital of Nanchang University /ID# 262085
Nanchang, Jiangxi, China, 330008
Actively Recruiting
9
Liaoning Cancer Hospital & Institute /ID# 268023
Shenyang, Liaoning, China, 110042
Actively Recruiting
10
Zhongshan Hospital Fudan University /ID# 262135
Shanghai, Shanghai Municipality, China, 200032
Actively Recruiting
11
Zhejiang Cancer hospital /ID# 262046
Hangzhou, Zhejiang, China, 310022
Actively Recruiting
Research Team
A
ABBVIE CALL CENTER
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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