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

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.

Study Overview

• Status: Recruiting
• Conditions: Hepatocellular Carcinoma (HCC)
• Intervention / Treatment: Drug: Livmoniplimab; Drug: Budigalimab

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: ABBVIE CALL CENTER; Phone Number: 844-663-3742; Email: abbvieclinicaltrials@abbvie.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100069
      • Recruiting
      • Beijing Youan Hospital, Capital Medical University -No differernce with previous /ID# 261928
  • Fujian
    • Fuzhou, Fujian, China, 350012
      • Recruiting
      • Mengchao Hepatobiliary Hospital of Fujian Medical University /ID# 262443
  • Guangdong
    • Guangzhou, Guangdong, China, 510515
      • Recruiting
      • Nanfang Hospital of Southern Medical University /ID# 262091
    • Guangzhou, Guangdong, China, 510060
      • Recruiting
      • Sun Yat-Sen University Cancer Center /ID# 262092
  • Heilongjiang
    • Harbin, Heilongjiang, China, 150081
      • Recruiting
      • Harbin Medical University Cancer Hospital /Id# 262070
  • Henan
    • Zhengzhou, Henan, China, 450008
      • Recruiting
      • Henan Cancer Hospital /ID# 262098
  • Hubei
    • Wuhan, Hubei, China, 430079
      • Recruiting
      • Hubei Cancer Hospital /ID# 262030
  • Jiangxi
    • Nanchang, Jiangxi, China, 330008
      • Recruiting
      • The Second Affiliated Hospital of Nanchang University /ID# 262085
  • Liaoning
    • Shenyang, Liaoning, China, 110042
      • Recruiting
      • Liaoning Cancer Hospital & Institute /ID# 268023
  • Shanghai
    • Shanghai, Shanghai, China, 200032
      • Recruiting
      • Zhongshan Hospital Fudan University /ID# 262135
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310022
      • Recruiting
      • Zhejiang Cancer hospital /ID# 262046

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Stage 1: Cohort 1 Livmoniplimab + Budigalimab Dose A; Participants will receive livmoniplimab Dose A in combination with budigalimab every 3 weeks for approximately 2 years.	Drug: Livmoniplimab; Intravenous infusion; Other Names: ABBV-151; Drug: Budigalimab; Intravenous infusion; Other Names: ABBV-181
Experimental: Stage 2: Cohort 2 Livmoniplimab + Budigalimab Dose B; Participants will receive livmoniplimab Dose B in combination with budigalimab every 3 weeks for approximately 2 years.	Drug: Livmoniplimab; Intravenous infusion; Other Names: ABBV-151; Drug: Budigalimab; Intravenous infusion; Other Names: ABBV-181

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants With Adverse Events (AE)	An adverse event is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment.	Up to Approximately 2 Years
Number of Participants with Dose-Limiting Toxicities (DLT)	DLT events are defined as clinically significant adverse events or abnormal laboratory values assessed as unrelated to disease progression, underlying disease, intercurrent illness, or concomitant medications.	Up to Approximately 2 Years
Maximum Plasma Concentration (Cmax) of Livmoniplimab and Budigalimab	Maximum Plasma Concentration (Cmax) of livmoniplimab and Budigalimab	Up to Approximately 2 Years
Area Under the Serum Concentration Versus Time Curve (AUC) of Livmoniplimab and Budigalimab	AUC of livmoniplimab and Budigalimab	Up to Approximately 2 Years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Best Overall Response (BOR) for Participants with Confirmed CR/PR per RECIST v1.1	Defined as achieving either confirmed CR or confirmed PR per RECIST v1.1 as assessed by the investigator.	Up to Approximately 2 Years
Duration of response (DOR) for Participants with Confirmed CR/PR	Defined as the time from the participant's initial response (CR or PR) to the first occurrence of radiographic progression per RECIST v1.1 as determined by the investigator or death from any cause.	Up to Approximately 2 Years
Progression-free survival (PFS)	Defined as the time from the participant's first dose of study drug until radiographic progression per RECIST v1.1 as determined by the investigator or death from any cause, whichever occurs first.	Up to Approximately 2 Years
Overall survival (OS)	Defined as the time from the participant's first dose of study drug until death from any cause.	Up to Approximately 2 Years
Antidrug Antibody (ADA)	Incidence and concentration of anti-drug antibodies.	Up to Approximately 2 Years
Neutralizing Antidrug Antibody (nADA)	Incidence and concentration of neutralizing anti-drug antibodies.	Up to Approximately 2 Years

Collaborators and Investigators

• Sponsor: AbbVie
• Investigators: Study Director: ABBVIE INC., AbbVie

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): September 11, 2024
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): October 1, 2027

Study Registration Dates

• First Submitted: June 28, 2024
• First Submitted That Met QC Criteria: June 28, 2024
• First Posted (Actual): July 5, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 28, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: ABBV-181; Hepatocellular Carcinoma (HCC); budigalimab; Livmoniplimab; ABBV-151
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Neoplasms by Histologic Type; Digestive System Neoplasms; Digestive System Diseases; Liver Diseases; Neoplasms, Glandular and Epithelial; Adenocarcinoma; Liver Neoplasms; Carcinoma; Carcinoma, Hepatocellular
• Other Study ID Numbers: M24-695

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No