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Trial 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)
NCT ID:
NCT06487559
Condition:
Hepatocellular Carcinoma (HCC)
Conditions: Official terms:
Carcinoma
Carcinoma, Hepatocellular
Conditions: Keywords:
Hepatocellular Carcinoma (HCC)
Livmoniplimab
ABBV-151
budigalimab
ABBV-181
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Sequential Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Livmoniplimab
Description:
Intravenous infusion
Arm group label:
Stage 1: Cohort 1 Livmoniplimab + Budigalimab Dose A
Arm group label:
Stage 2: Cohort 2 Livmoniplimab + Budigalimab Dose B
Other name:
ABBV-151
Intervention type:
Drug
Intervention name:
Budigalimab
Description:
Intravenous infusion
Arm group label:
Stage 1: Cohort 1 Livmoniplimab + Budigalimab Dose A
Arm group label:
Stage 2: Cohort 2 Livmoniplimab + Budigalimab Dose B
Other name:
ABBV-181
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.
Criteria for eligibility:
Criteria:
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Mengchao Hepatobiliary Hospital of Fujian Medical University /ID# 262443
Address:
City:
Fuzhou
Zip:
350012
Country:
China
Status:
Recruiting
Facility:
Name:
Nanfang Hospital of Southern Medical University /ID# 262091
Address:
City:
Guangzhou
Zip:
510515
Country:
China
Status:
Recruiting
Facility:
Name:
Hubei Cancer Hospital /ID# 262030
Address:
City:
Wuhan
Zip:
430079
Country:
China
Status:
Recruiting
Facility:
Name:
The Second Affiliated Hospital of Nanchang University /ID# 262085
Address:
City:
Nanchang
Zip:
330008
Country:
China
Status:
Recruiting
Facility:
Name:
Zhongshan Hospital Fudan University /ID# 262135
Address:
City:
Shanghai
Zip:
200032
Country:
China
Status:
Recruiting
Facility:
Name:
Zhejiang Cancer hospital /ID# 262046
Address:
City:
Hangzhou
Zip:
310022
Country:
China
Status:
Recruiting
Start date:
September 11, 2024
Completion date:
October 27, 2027
Lead sponsor:
Agency:
AbbVie
Agency class:
Industry
Source:
AbbVie
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06487559
https://www.abbvieclinicaltrials.com/study/?id=M24-695
