RecruitingPhase 1NCT06487559

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


Sponsor

AbbVie

Enrollment

20 participants

Start Date

Sep 11, 2024

Study Type

INTERVENTIONAL

Conditions

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 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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is studying how two immune-boosting drugs — livmoniplimab and budigalimab — move through the body and their safety profile when given together by IV infusion to Chinese adults with advanced liver cancer (hepatocellular carcinoma) that cannot be removed by surgery. **You may be eligible if...** - You have locally advanced, metastatic, or unresectable liver cancer - Your liver is still functioning reasonably well (Child-Pugh A) - Your cancer is intermediate or advanced stage (Barcelona Clinic stage B or C) - You have previously received an immune checkpoint inhibitor as part of your first-line treatment - You have a good performance status (ECOG 0-1) - Your blood counts and organ function are adequate **You may NOT be eligible if...** - You have untreated cancer spread to the brain or spinal cord - You have had another type of cancer in the past 5 years (some low-risk exceptions apply) - You have a history of autoimmune conditions (e.g., lupus, inflammatory bowel disease, rheumatoid arthritis) - You have had significant heart, kidney, lung, or liver problems in the last 6 months Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGLivmoniplimab

Intravenous infusion

DRUGBudigalimab

Intravenous infusion


Locations(11)

Beijing Youan Hospital, Capital Medical University -No differernce with previous /ID# 261928

Beijing, Beijing Municipality, China

Mengchao Hepatobiliary Hospital of Fujian Medical University /ID# 262443

Fuzhou, Fujian, China

Sun Yat-Sen University Cancer Center /ID# 262092

Guangzhou, Guangdong, China

Nanfang Hospital of Southern Medical University /ID# 262091

Guangzhou, Guangdong, China

Harbin Medical University Cancer Hospital /Id# 262070

Harbin, Heilongjiang, China

Henan Cancer Hospital /ID# 262098

Zhengzhou, Henan, China

Hubei Cancer Hospital /ID# 262030

Wuhan, Hubei, China

The Second Affiliated Hospital of Nanchang University /ID# 262085

Nanchang, Jiangxi, China

Liaoning Cancer Hospital & Institute /ID# 268023

Shenyang, Liaoning, China

Zhongshan Hospital Fudan University /ID# 262135

Shanghai, Shanghai Municipality, China

Zhejiang Cancer hospital /ID# 262046

Hangzhou, Zhejiang, China

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NCT06487559


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