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Clinical Trials List

Protocol NumberM24-147
NCT Number(ClinicalTrials.gov Identfier)NCT05822752
Active

2023-09-01 - 2027-04-30

Phase II

Not yet recruiting3

Recruiting6

A Phase 2, Randomized Study to Evaluate the Optimized Dose, Safety, and Efficacy of Livmoniplimab in Combination With Budigalimab for Locally Advanced or Metastatic Hepatocellular Carcinoma (HCC) Patients Who Have Progressed After an Immune Checkpoint Inhibitor Containing Regimen in First-Line HCC

  • Trial Applicant

    AbbVie

  • Sponsor

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2026/02/01

Investigators and Locations

Principal Investigator Sheng-Shun Yang Digestive System Department
Taichung Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Not yet recruiting

Principal Investigator TSUNG-HAO LIU Division of Hematology & Oncology
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Yi-Hsiang Huang Division of Family Medicine
Taipei Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Ming-Lung Yu 無
Kaohsiung Medical Univeristy Chung-Ho Memorial Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Chang-Fang Chiu Division of Hematology & Oncology
China Medical University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator
Linkou Chang Gung Medical Foundation

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Not yet recruiting

Principal Investigator 盧勝男 Digestive System Department
Kaoshiung Chang Gung Memorial Hospital of the C.G.M.F.

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Not yet recruiting

Principal Investigator Chia-Jui Yen Division of General Internal Medicine
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 饒坤銘 Division of Hematology & Oncology
E-DA Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Condition/Disease

Hepatocellular Carcinoma

Objectives

main target 1. Optimize the dose of livmoniplimab and budigalimab combination therapy and identify recommended phase 3 doses in patients with locally advanced or metastatic Child-Pugh A HCC who progressed after a 1L HCC course with an immune-CPI. 2. Evaluate the efficacy of the combination of livmoniplimab and budigalimab as measured by the best overall response (BOR) rate of confirmed complete response (CR)/partial response (PR) as determined by the trial moderator. secondary goals 1. Evaluate the efficacy of the combination of livmoniplimab and budigalimab as measured by duration of response (DoR) as judged by the trial moderator, progression-free survival (PFS) as judged by the trial moderator, and overall survival (OS). 2. To evaluate the safety, tolerability, immunogenicity and pharmacokinetics (PK) of livmoniplimab and budigalimab combination therapy.

Test Drug

Budigalimab (ABBV-181)；Livmoniplimab (ABBV-151)

Active Ingredient

Budigalimab (ABBV-181)
Livmoniplimab (ABBV-151)

Dosage Form

Powder for Solution for Infusion
Solution for Infusion

Dosage

NA

Endpoints

The primary trial endpoint was best overall response (BOR) of confirmed complete response (CR) or confirmed partial response (PR) according to RECIST 1.1 as determined by the trial moderator at any time point before subsequent anticancer treatment.

Inclution Criteria

Inclusion Criteria:

Child-Pugh A classification.
Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1.
Received an immune checkpoint inhibitor in first-line (1L) hepatocellular carcinoma (HCC) treatment regimen.
Adequate hematologic and end-organ function.
Tissue biopsy at screening.
Disease that is not amenable to surgical and/or locoregional therapies, or progressive disease after surgical and /or locoregional therapies.

Exclusion Criteria

Exclusion Criteria:

Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases.
Prior treatment with an approved tyrosine kinase inhibitor (for example sorafenib or Lenvatinib) in 1L HCC treatment regimen.
History of malignancy other than hepatocellular carcinoma (HCC) within 5 years prior to screening.
Hepatic encephalopathy or requirement for medications to prevent or control encephalopathy.
Moderate or severe ascites requiring recurrent non-pharmacologic intervention to maintain symptomatic control.
Coinfection with active HBV infection and active HCV infection.
Prior history of grade 3 or higher immune-mediated adverse event or discontinuation due to immune-mediated adverse events.
Prior history of recurrent grade 2 or higher interstitial lung disease/pneumonitis.

The Estimated Number of Participants

  • Taiwan

    24 participants

  • Global

    120 participants

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