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)

NCT06487559 | Recruiting Phase 1

• 1 other identifier: M24-695
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 11

Brief 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.

Conditions

Hepatocellular Carcinoma (HCC)

Keywords

Hepatocellular Carcinoma (HCC); Livmoniplimab; ABBV-151; budigalimab; ABBV-181

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (6)

• Best Overall Response (BOR) for Participants with Confirmed CR/PR per RECIST v1.1

  Up to Approximately 2 Years

• Duration of response (DOR) for Participants with Confirmed CR/PR

  Up to Approximately 2 Years

• Progression-free survival (PFS)

  Up to Approximately 2 Years

• Overall survival (OS)

  Up to Approximately 2 Years

• Antidrug Antibody (ADA)

  Up to Approximately 2 Years

Study Arms (2)

Stage 1: Cohort 1 Livmoniplimab + Budigalimab Dose A

EXPERIMENTAL

Participants will receive livmoniplimab Dose A in combination with budigalimab every 3 weeks for approximately 2 years.

Drug: Livmoniplimab; Drug: Budigalimab

Stage 2: Cohort 2 Livmoniplimab + Budigalimab Dose B

EXPERIMENTAL

Participants will receive livmoniplimab Dose B in combination with budigalimab every 3 weeks for approximately 2 years.

Drug: Livmoniplimab; Drug: Budigalimab

Interventions

Livmoniplimab DRUG

Intravenous infusion

Also known as: ABBV-151

Stage 1: Cohort 1 Livmoniplimab + Budigalimab Dose A; Stage 2: Cohort 2 Livmoniplimab + Budigalimab Dose B

Budigalimab DRUG

Intravenous infusion

Also known as: ABBV-181

Stage 1: Cohort 1 Livmoniplimab + Budigalimab Dose A; Stage 2: Cohort 2 Livmoniplimab + Budigalimab Dose B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• AbbVie: lead

Study Sites (11)

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

Beijing, Beijing Municipality, 100069, China

RECRUITING

Mengchao Hepatobiliary Hospital of Fujian Medical University /ID# 262443

Fuzhou, Fujian, 350012, China

RECRUITING

Sun Yat-Sen University Cancer Center /ID# 262092

Guangzhou, Guangdong, 510060, China

RECRUITING

Nanfang Hospital of Southern Medical University /ID# 262091

Guangzhou, Guangdong, 510515, China

RECRUITING

Harbin Medical University Cancer Hospital /Id# 262070

Harbin, Heilongjiang, 150081, China

RECRUITING

Henan Cancer Hospital /ID# 262098

Zhengzhou, Henan, 450008, China

RECRUITING

Hubei Cancer Hospital /ID# 262030

Wuhan, Hubei, 430079, China

RECRUITING

The Second Affiliated Hospital of Nanchang University /ID# 262085

Nanchang, Jiangxi, 330008, China

RECRUITING

Liaoning Cancer Hospital & Institute /ID# 268023

Shenyang, Liaoning, 110042, China

RECRUITING

Zhongshan Hospital Fudan University /ID# 262135

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

Zhejiang Cancer hospital /ID# 262046

Hangzhou, Zhejiang, 310022, China

RECRUITING

Related Links

• Related Info

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

budigalimab

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Study Officials

• ABBVIE INC.

  AbbVie

  STUDY DIRECTOR

Central Study Contacts

ABBVIE CALL CENTER

CONTACT

844-663-3742; abbvieclinicaltrials@abbvie.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 28, 2024
• First Posted: July 5, 2024
• Study Start: September 11, 2024
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): October 1, 2027
• Last Updated: March 4, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (11)