Actively Recruiting

Phase 1
Age: 18Years +
All Genders
NCT06487559

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)

Led by AbbVie · Updated on 2025-03-04

20

Participants Needed

11

Research Sites

159 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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)

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults with locally advanced or metastatic and/or unresectable hepatocellular carcinoma (HCC)
  • Child-Pugh A liver function classification
  • Barcelona Clinic Liver Cancer stage B or C
  • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
  • Received an immune checkpoint inhibitor in first-line HCC treatment
  • Adequate blood counts and organ function
Not Eligible

You will not qualify if you...

  • Untreated, symptomatic, or actively worsening central nervous system metastases
  • History of other cancers within 5 years except those with very low risk of spread or death
  • History of autoimmune, immune deficiency, or inflammatory disorders such as lupus, rheumatoid arthritis, or multiple sclerosis
  • Clinically significant kidney, nerve, psychiatric, hormone, metabolic, immune, heart, lung, or liver disease within the last 6 months that may interfere with study participation

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 11 locations

1

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

Beijing, Beijing Municipality, China, 100069

Actively Recruiting

2

Mengchao Hepatobiliary Hospital of Fujian Medical University /ID# 262443

Fuzhou, Fujian, China, 350012

Actively Recruiting

3

Sun Yat-Sen University Cancer Center /ID# 262092

Guangzhou, Guangdong, China, 510060

Actively Recruiting

4

Nanfang Hospital of Southern Medical University /ID# 262091

Guangzhou, Guangdong, China, 510515

Actively Recruiting

5

Harbin Medical University Cancer Hospital /Id# 262070

Harbin, Heilongjiang, China, 150081

Actively Recruiting

6

Henan Cancer Hospital /ID# 262098

Zhengzhou, Henan, China, 450008

Actively Recruiting

7

Hubei Cancer Hospital /ID# 262030

Wuhan, Hubei, China, 430079

Actively Recruiting

8

The Second Affiliated Hospital of Nanchang University /ID# 262085

Nanchang, Jiangxi, China, 330008

Actively Recruiting

9

Liaoning Cancer Hospital & Institute /ID# 268023

Shenyang, Liaoning, China, 110042

Actively Recruiting

10

Zhongshan Hospital Fudan University /ID# 262135

Shanghai, Shanghai Municipality, China, 200032

Actively Recruiting

11

Zhejiang Cancer hospital /ID# 262046

Hangzhou, Zhejiang, China, 310022

Actively Recruiting

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Research Team

A

ABBVIE CALL CENTER

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

SEQUENTIAL

Primary Purpose

TREATMENT

Number of Arms

2

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