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NCT06487559 · ClinicalTrials.gov record · last posted 2026-08-17

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)

StatusActive, Not Recruiting
PhasePhase 1
SponsorAbbVie
Started2024-09-11
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from the ClinicalTrials.gov record
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.

Protocol amendment history 4 changes detected by DataLookout

2026-08-18
notable
Enrollment closed, study ongoing
2026-08-18
critical
Enrollment reduced: 20 → 3 participants
2026-08-18
minor
Primary completion moved earlier: 2027-10 → 2027-02
2026-08-18
minor
Completion moved earlier: 2027-10 → 2027-02
Trial Details
NCT Number NCT06487559
Lead Sponsor AbbVie
Conditions Hepatocellular Carcinoma (HCC)
Enrollment 3 participants
Start Date 2024-09-11
Primary Completion 2027-02 (estimated)
Study Completion 2027-02 (estimated)
Updated on ClinicalTrials.gov 2026-08-17