Clinical trial 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)
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Hepatocellular Carcinoma (HCC)
Keywords: Hepatocellular Carcinoma (HCC)
Livmoniplimab
ABBV-151
budigalimab
ABBV-181
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2024-07-05
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Percentage of Participants With Adverse Events (AE)
timeFrame: Up to Approximately 2 Years
measure: Number of Participants with Dose-Limiting Toxicities (DLT)
timeFrame: Up to Approximately 2 Years
measure: Maximum Plasma Concentration (Cmax) of Livmoniplimab and Budigalimab
timeFrame: Up to Approximately 2 Years
measure: Area Under the Serum Concentration Versus Time Curve (AUC) of Livmoniplimab and Budigalimab
timeFrame: Up to Approximately 2 Years
Secondary outcomes:
measure: Best Overall Response (BOR) for Participants with Confirmed CR/PR per RECIST v1.1
timeFrame: Up to Approximately 2 Years
measure: Duration of response (DOR) for Participants with Confirmed CR/PR
timeFrame: Up to Approximately 2 Years
measure: Progression-free survival (PFS)
timeFrame: Up to Approximately 2 Years
measure: Overall survival (OS)
timeFrame: Up to Approximately 2 Years
measure: Antidrug Antibody (ADA)
timeFrame: Up to Approximately 2 Years
measure: Neutralizing Antidrug Antibody (nADA)
timeFrame: Up to Approximately 2 Years
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Youan Hospital, Capital Medical University -No differernce with previous /ID# 261928
state: Beijing
city: Fuzhou
country: China
facility: Mengchao Hepatobiliary Hospital of Fujian Medical University /ID# 262443
state: Fujian
city: Guangzhou
country: China
facility: Sun Yat-Sen University Cancer Center /ID# 262092
state: Guangdong
city: Guangzhou
country: China
facility: Nanfang Hospital of Southern Medical University /ID# 262091
state: Guangdong
city: Harbin
country: China
facility: Harbin Medical University Cancer Hospital /Id# 262070
state: Heilongjiang
city: Zhengzhou
country: China
facility: Henan Cancer Hospital /ID# 262098
state: Henan
city: Wuhan
country: China
facility: Hubei Cancer Hospital /ID# 262030
state: Hubei
city: Nanchang
country: China
facility: The Second Affiliated Hospital of Nanchang University /ID# 262085
state: Jiangxi
city: Shenyang
country: China
facility: Liaoning Cancer Hospital & Institute /ID# 268023
state: Liaoning
city: Shanghai
country: China
facility: Zhongshan Hospital Fudan University /ID# 262135
state: Shanghai
city: Hangzhou
country: China
facility: Zhejiang Cancer hospital /ID# 262046
state: Zhejiang
Study officials:
affiliation: AbbVie
name: ABBVIE INC.
role: STUDY_DIRECTOR
References: