OncoMatch/Clinical Trials/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)
Is NCT06487559 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies multiple treatments including Livmoniplimab and Budigalimab for hepatocellular carcinoma (hcc).
Treatment: Livmoniplimab · Budigalimab — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Hepatocellular Carcinoma
Disease stage
Required: Stage BARCELONA CLINIC LIVER CANCER STAGE B, BARCELONA CLINIC LIVER CANCER STAGE C (Barcelona Clinic Liver Cancer)
Locally advanced or metastatic and/or unresectable HCC; Barcelona Clinic Liver Cancer stage B or C
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: checkpoint inhibitor — first-line HCC treatment
Received an immune checkpoint inhibitor in 1L HCC treatment regimen
Lab requirements
Blood counts
Adequate hematologic and end-organ function
Liver function
Child-Pugh A
Child-Pugh A; Adequate hematologic and end-organ function
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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