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
Last Updated: 2025-03-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
20 participants
INTERVENTIONAL
2024-09-11
2027-10-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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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.
Livmoniplimab
Intravenous infusion
Budigalimab
Intravenous infusion
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.
Livmoniplimab
Intravenous infusion
Budigalimab
Intravenous infusion
Interventions
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Livmoniplimab
Intravenous infusion
Budigalimab
Intravenous infusion
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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AbbVie
INDUSTRY
Responsible Party
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Principal Investigators
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ABBVIE INC.
Role: STUDY_DIRECTOR
AbbVie
Locations
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Beijing Youan Hospital, Capital Medical University -No differernce with previous /ID# 261928
Beijing, Beijing Municipality, China
Mengchao Hepatobiliary Hospital of Fujian Medical University /ID# 262443
Fuzhou, Fujian, China
Sun Yat-Sen University Cancer Center /ID# 262092
Guangzhou, Guangdong, China
Nanfang Hospital of Southern Medical University /ID# 262091
Guangzhou, Guangdong, China
Harbin Medical University Cancer Hospital /Id# 262070
Harbin, Heilongjiang, China
Henan Cancer Hospital /ID# 262098
Zhengzhou, Henan, China
Hubei Cancer Hospital /ID# 262030
Wuhan, Hubei, China
The Second Affiliated Hospital of Nanchang University /ID# 262085
Nanchang, Jiangxi, China
Liaoning Cancer Hospital & Institute /ID# 268023
Shenyang, Liaoning, China
Zhongshan Hospital Fudan University /ID# 262135
Shanghai, Shanghai Municipality, China
Zhejiang Cancer hospital /ID# 262046
Hangzhou, Zhejiang, China
Countries
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Central Contacts
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Related Links
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Other Identifiers
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M24-695
Identifier Type: -
Identifier Source: org_study_id
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