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)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Livmoniplimab, Budigalimab.
- Who it may be relevant to
- Registry conditions: Hepatocellular Carcinoma (HCC). Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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
Overview
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.
Interventions
- Drug Livmoniplimab
Intravenous infusion - Drug Budigalimab
Intravenous infusion
Primary outcome measures
- Percentage of Participants With Adverse Events (AE) [Time frame: Up to Approximately 2 Years]
- Number of Participants with Dose-Limiting Toxicities (DLT) [Time frame: Up to Approximately 2 Years]
- Maximum Plasma Concentration (Cmax) of Livmoniplimab and Budigalimab [Time frame: Up to Approximately 2 Years]
- Area Under the Serum Concentration Versus Time Curve (AUC) of Livmoniplimab and Budigalimab [Time frame: Up to Approximately 2 Years]
Secondary outcome measures (6)
- Best Overall Response (BOR) for Participants with Confirmed CR/PR per RECIST v1.1 [Time frame: Up to Approximately 2 Years]
- Duration of response (DOR) for Participants with Confirmed CR/PR [Time frame: Up to Approximately 2 Years]
- Progression-free survival (PFS) [Time frame: Up to Approximately 2 Years]
- Overall survival (OS) [Time frame: Up to Approximately 2 Years]
- Antidrug Antibody (ADA) [Time frame: Up to Approximately 2 Years]
- Neutralizing Antidrug Antibody (nADA) [Time frame: Up to Approximately 2 Years]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Sequential
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 11 centers
- Beijing Youan Hospital, Capital Medical University -No differernce with previous /ID# 2619 — Beijing
- Mengchao Hepatobiliary Hospital of Fujian Medical University /ID# 262443 — Fuzhou
- Sun Yat-Sen University Cancer Center /ID# 262092 — Guangzhou
- Nanfang Hospital of Southern Medical University /ID# 262091 — Guangzhou
- Harbin Medical University Cancer Hospital /Id# 262070 — Harbin
- Henan Cancer Hospital /ID# 262098 — Zhengzhou
- Hubei Cancer Hospital /ID# 262030 — Wuhan
- The Second Affiliated Hospital of Nanchang University /ID# 262085 — Nanchang
- … and 3 more centers
Identifiers
NCT: NCT06487559 · M24-695