NCT06487559TerminatedPhase 1
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)
A Phase 1b Study to Evaluate the Safety and Pharmacokinetics of Livmoniplimab in Combination With Budigalimab in Chinese Subjects With Locally Advanced or Metastatic Child-Pugh A Hepatocellular Carcinoma Who Have Progressed After a First-Line Regimen That Includes an Immune Checkpoint Inhibitor
Source: ClinicalTrials.gov · Last updated 21 Oct 2026
Reason given: Strategic considerations
Brief summary (registry, in English)
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.
- Status (registry)
- Terminated
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 3 (actual)
- First submitted
- 28 Jun 2024
- Start date
- 11 Sept 2024
- Primary completion date
- 18 Sept 2026
- Lead sponsor
- AbbVie
- Diseases
- Liver and biliary tract cancer
- NCT number
- NCT06487559
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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.
Other
- Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases as outlined in the protocol.
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (11)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Beijing Youan Hospital, Capital Medical University -No differernce with previous /ID# 261928 | Beijing | China | Unknown status |
| Mengchao Hepatobiliary Hospital of Fujian Medical University /ID# 262443 | Fuzhou | China | Unknown status |
| Sun Yat-Sen University Cancer Center /ID# 262092 | Guangzhou | China | Unknown status |
| Nanfang Hospital of Southern Medical University /ID# 262091 | Guangzhou | China | Unknown status |
| Zhejiang Cancer hospital /ID# 262046 | Hangzhou | China | Unknown status |
| Harbin Medical University Cancer Hospital /Id# 262070 | Harbin | China | Unknown status |
| The Second Affiliated Hospital of Nanchang University /ID# 262085 | Nanchang | China | Unknown status |
| Zhongshan Hospital Fudan University /ID# 262135 | Shanghai | China | Unknown status |
| Liaoning Cancer Hospital & Institute /ID# 268023 | Shenyang | China | Unknown status |
| Hubei Cancer Hospital /ID# 262030 | Wuhan | China | Unknown status |
| Henan Cancer Hospital /ID# 262098 | Zhengzhou | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.