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)
NCT Number: NCT06487559
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Hepatocellular Carcinoma (HCC)
Interventions: DRUG: Livmoniplimab|DRUG: Budigalimab
Sponsor: AbbVie
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 20
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: SEQUENTIAL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-10-05
Completion Date: 2027-10-27

Summary:
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.

Primary Outcome Measures: Percentage of Participants With Adverse Events (AE), An adverse event is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment., Up to Approximately 2 Years|Number of Participants with Dose-Limiting Toxicities (DLT), DLT events are defined as clinically significant adverse events or abnormal laboratory values assessed as unrelated to disease progression, underlying disease, intercurrent illness, or concomitant medications., Up to Approximately 2 Years|Maximum Plasma Concentration (Cmax) of Livmoniplimab and Budigalimab, Maximum Plasma Concentration (Cmax) of livmoniplimab and Budigalimab, Up to Approximately 2 Years|Area Under the Serum Concentration Versus Time Curve (AUC) of Livmoniplimab and Budigalimab, AUC of livmoniplimab and Budigalimab, Up to Approximately 2 Years
Secondary Outcome Measures: Best Overall Response (BOR) for Participants with Confirmed CR/PR per RECIST v1.1, Defined as achieving either confirmed CR or confirmed PR per RECIST v1.1 as assessed by the investigator., Up to Approximately 2 Years|Duration of response (DOR) for Participants with Confirmed CR/PR, Defined as the time from the participant's initial response (CR or PR) to the first occurrence of radiographic progression per RECIST v1.1 as determined by the investigator or death from any cause., Up to Approximately 2 Years|Progression-free survival (PFS), Defined as the time from the participant's first dose of study drug until radiographic progression per RECIST v1.1 as determined by the investigator or death from any cause, whichever occurs first., Up to Approximately 2 Years|Overall survival (OS), Defined as the time from the participant's first dose of study drug until death from any cause., Up to Approximately 2 Years|Antidrug Antibody (ADA), Incidence and concentration of anti-drug antibodies., Up to Approximately 2 Years|Neutralizing Antidrug Antibody (nADA), Incidence and concentration of neutralizing anti-drug antibodies., Up to Approximately 2 Years