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)

StatusTerminated
PhasePhase 1
SponsorAbbVie
Started

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Record History

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  1. Stopped Trial terminated Sponsor's reason: Strategic considerations Show 4 more changesShow less
    • Primary completion date changed from estimate of Feb 2027 to Sep 18, 2026
    • Eligibility criteria expanded, about 10 words
    • Secondary endpoints: details revised at 4 of 6 entries
    • Site details revised at 11 of 11 sites
  2. Notable Enrollment reduced: 20 → 3 participants
    • Enrollment closed, study ongoing
    • Primary and study completion moved earlier from Oct 2027 to Feb 2027
    • Site details revised at 11 of 11 sites
    v15
  3. Minor Study sites: 10 to 11v14
  4. Re-verified, no change to tracked fieldsv13
  5. Minor Study sites: 9 to 10v12
Show 10 earlier versionsHide 10 earlier versions
  1. Minor Study sites: 8 to 9v11
  2. Minor Study sites: 7 to 8v10
  3. Minor Study sites: 6 to 7v9
  4. Minor Primary and study completion dates: Oct 27, 2027 to Oct 2027v8
  5. Minor Study sites: 4 to 6v7
  6. Re-verified, no change to tracked fieldsv6
  7. Minor Study sites: 3 to 4v5
  8. Minor Study sites: 2 to 3v4
  9. Minor Study sites: 1 to 2v3
  10. Notable Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    • Start date changed from estimate of Oct 5, 2024 to Sep 11, 2024
    v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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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.
Trial Details
NCT Number NCT06487559
Lead Sponsor AbbVie
Conditions
(from sponsor)
Hepatocellular Carcinoma (HCC)
Related terms Carcinoma, Hepatocellular
Enrollment 3 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov