Assessing the effects of Livmoniplimab and Budigalimab in treating advanced liver cancer in adults
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
This study is testing a new combination of two drugs, Livmoniplimab and Budigalimab, to see if they can safely help adults in China with advanced liver cancer.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | AbbVie Industry-sponsored |
| Drugs / interventions | livmoniplimab, budigalimab |
| Locations | 11 sites (Beijing, Beijing Municipality and 10 other locations) |
| Trial ID | NCT06487559 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the safety and pharmacokinetics of Livmoniplimab, an investigational drug, in combination with Budigalimab for adult Chinese participants with locally advanced or metastatic hepatocellular carcinoma (HCC). The study consists of two stages: a safety run-in with escalating doses of Livmoniplimab and a dose expansion phase with multiple doses. Approximately 20 participants will be enrolled across 15 sites in China, focusing on those with Child-Pugh A liver function. The trial aims to gather data on adverse events and how the drugs move through the body.
Who should consider this trial
Good fit: Ideal candidates include adults with locally advanced or metastatic HCC who have Child-Pugh A liver function and have previously received an immune checkpoint inhibitor.
Not a fit: Patients with symptomatic or untreated central nervous system metastases or a history of significant autoimmune disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new treatment option for patients with advanced liver cancer.
How similar studies have performed: While this approach is novel, similar studies involving immune checkpoint inhibitors have shown promise in treating various cancers.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Beijing, Beijing Municipality and 10 other locations
- Beijing Youan Hospital, Capital Medical University -No differernce with previous /ID# 261928 — Beijing, Beijing Municipality, China (Recruiting)
- Mengchao Hepatobiliary Hospital of Fujian Medical University /ID# 262443 — Fuzhou, Fujian, China (Recruiting)
- Sun Yat-Sen University Cancer Center /ID# 262092 — Guangzhou, Guangdong, China (Recruiting)
- Nanfang Hospital of Southern Medical University /ID# 262091 — Guangzhou, Guangdong, China (Recruiting)
- Harbin Medical University Cancer Hospital /Id# 262070 — Harbin, Heilongjiang, China (Recruiting)
- Henan Cancer Hospital /ID# 262098 — Zhengzhou, Henan, China (Recruiting)
- Hubei Cancer Hospital /ID# 262030 — Wuhan, Hubei, China (Recruiting)
- The Second Affiliated Hospital of Nanchang University /ID# 262085 — Nanchang, Jiangxi, China (Recruiting)
- Liaoning Cancer Hospital & Institute /ID# 268023 — Shenyang, Liaoning, China (Recruiting)
- Zhongshan Hospital Fudan University /ID# 262135 — Shanghai, Shanghai Municipality, China (Recruiting)
- Zhejiang Cancer hospital /ID# 262046 — Hangzhou, Zhejiang, China (Recruiting)
Study contacts
- Study coordinator: Abbvie Call Center
- Email: abbvieclinicaltrials@abbvie.com
- Phone: 844-663-3742
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.