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Clinical Trials List

Protocol NumberM24-052

NCT Number(ClinicalTrials.gov Identfier)NCT06109272

Active

2024-01-01 - 2030-11-30

Phase II/III

Recruiting5

A Phase 2/3, Randomized Study to Evaluate the Dose Optimization, Safety, and Efficacy of Livmoniplimab in Combination With Budigalimab in Subjects With Locally Advanced or Metastatic Hepatocellular Carcinoma (HCC) Who Have Not Previously Received Systemic Treatment

Trial Applicant

AbbVie
Sponsor
Trial scale

Multi-Regional Multi-Center
Update

2026/06/18

Investigators and Locations

Principal Investigator Chang-Fang Chiu 無

China Medical University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Ann-Lii Cheng 無

National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator

Taichung Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Yi-Hsiang Huang 無

Taipei Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Chia-Jui Yen

National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Condition/Disease

Hepatocellular Carcinoma

Objectives

Primary Objectives Phase 1 - To select the optimal dose of livmoniplimab in combination with budigalimab from a Phase 3 trial in patients with locally advanced or metastatic hepatocellular carcinoma (HCC) who have not previously received systemic therapy for HCC. Phase 2 - To evaluate the efficacy of livmoniplimab and budigalimab in combination as an overall survival (OS) in patients with locally advanced or metastatic HCC who have not previously received systemic therapy for HCC. Secondary Objectives Phase 1 and 2 - To evaluate the safety, tolerability, immunogenicity, and pharmacokinetics (PK) of livmoniplimab in combination with budigalimab. Phase 2 - To evaluate the efficacy of livmoniplimab in combination with budigalimab based on progression-free survival (PFS), best overall response (BOR) (complete response)/partial response (PR), and duration of response (DoR). Phase 2 - Evaluate the effects of livmoniplimab and budigalimab on patient-reported outcomes (PROs).

Test Drug

N/A
N/A

Active Ingredient

Livmoniplimab
Budigalimab

Dosage Form

N/A
N/A

Dosage

NA
NA

Endpoints

The primary endpoint for Phase 1 is the BOR of CR/PR as assessed by the trial administrator according to RECIST 1.1.

The primary endpoint for Phase 2 is OS.

Inclution Criteria

Inclusion Criteria:

Locally advanced or metastatic and/or unresectable hepatocellular carcinoma (HCC) with diagnosis confirmed by histology or cytology or clinically by American Association for the Study of Liver Diseases criteria for participants with cirrhosis.
Barcelona Clinic Liver Cancer (BCLC) Stage B or C.
Child-Pugh A or B7 classification (i.e., total Child-Pugh score of 5, 6, or 7).
Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1.

Exclusion Criteria

Exclusion Criteria:

Prior systemic therapy for HCC.
Symptomatic, untreated, or actively progressing CNS metastases.
History of malignancy other than HCC.

The Estimated Number of Participants

Taiwan

26 participants
Global

660 participants