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

Status: Recruiting
Location: See all (11) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
China
Beijing Youan Hospital, Capital Medical University -No differernce with previous /ID# 261928
RECRUITING
Beijing
Mengchao Hepatobiliary Hospital of Fujian Medical University /ID# 262443
RECRUITING
Fuzhou
Nanfang Hospital of Southern Medical University /ID# 262091
RECRUITING
Guangzhou
Sun Yat-Sen University Cancer Center /ID# 262092
RECRUITING
Guangzhou
Zhejiang Cancer hospital /ID# 262046
RECRUITING
Hangzhou
Harbin Medical University Cancer Hospital /Id# 262070
RECRUITING
Harbin
The Second Affiliated Hospital of Nanchang University /ID# 262085
RECRUITING
Nanchang
Zhongshan Hospital Fudan University /ID# 262135
RECRUITING
Shanghai
Liaoning Cancer Hospital & Institute /ID# 268023
RECRUITING
Shenyang
Hubei Cancer Hospital /ID# 262030
RECRUITING
Wuhan
Henan Cancer Hospital /ID# 262098
RECRUITING
Zhengzhou
Contact Information
Primary
ABBVIE CALL CENTER
abbvieclinicaltrials@abbvie.com
844-663-3742
Time Frame
Start Date: 2024-09-11
Estimated Completion Date: 2027-10
Participants
Target number of participants: 20
Treatments
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.
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.
Related Therapeutic Areas
Sponsors
Leads: AbbVie

This content was sourced from clinicaltrials.gov

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