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Active, not recruiting

NCT Number: NCT06487559

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)

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.

Active, not recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Hepatocellular Carcinoma (HCC) Adenocarcinoma Carcinoma Carcinoma, Hepatocellular Digestive System Diseases Digestive System Neoplasms Liver Diseases Liver Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Beijing Youan Hospital, Capital Medical University -No differernce with previous /ID# 261928, Beijing, Beijing Municipality, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Locally advanced or metastatic and/or unresectable HCC
  • Child-Pugh A
  • Barcelona Clinic Liver Cancer stage B or C
  • Eastern Cooperative Oncology Group (ECOG) Perfromance Status of 0-1
  • Received an immune checkpoint inhibitor in 1L HCC treatment regimen
  • Adequate hematologic and end-organ function

Exclusion criteria

  • Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases as outlined in the protocol.
  • History of malignancy other than HCC within 5 years prior to screening, except for malignancies with a negligible risk of metastasis or death (e.g., 5-year OS rate > 90%).
  • History of autoimmune, immune deficiency, or inflammatory disorders including, but not limited to, inflammatory bowel disease, systemic lupus erythematosus, sarcoidosis, Wegener syndrome, rheumatoid arthritis, antiphospholipid antibody syndrome, Guillain-Barre syndrome, or multiple sclerosis
  • History of clinically significant conditions such as but not limited to the following: renal, neurologic, psychiatric, endocrine, metabolic, immunologic, cardiovascular, pulmonary, or hepatic disease within the last 6 months that in Investigator's opinion, would adversely affect the subject's participation in the study.

Treatment and study plan

Livmoniplimab

Drug

Intravenous infusion

Other names: ABBV-151

Budigalimab

Drug

Intravenous infusion

Other names: ABBV-181

Primary outcomes

  1. Percentage of Participants With Adverse Events (AE)

    Time frame: Up to Approximately 2 Years

    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.

  2. Number of Participants with Dose-Limiting Toxicities (DLT)

    Time frame: Up to Approximately 2 Years

    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.

  3. Maximum Plasma Concentration (Cmax) of Livmoniplimab and Budigalimab

    Time frame: Up to Approximately 2 Years

    Maximum Plasma Concentration (Cmax) of livmoniplimab and Budigalimab

  4. Area Under the Serum Concentration Versus Time Curve (AUC) of Livmoniplimab and Budigalimab

    Time frame: Up to Approximately 2 Years

    AUC of livmoniplimab and Budigalimab

Secondary outcomes

  1. Best Overall Response (BOR) for Participants with Confirmed CR/PR per RECIST v1.1

    Time frame: Up to Approximately 2 Years

    Defined as achieving either confirmed CR or confirmed PR per RECIST v1.1 as assessed by the investigator.

  2. Duration of response (DOR) for Participants with Confirmed CR/PR

    Time frame: Up to Approximately 2 Years

    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.

  3. Progression-free survival (PFS)

    Time frame: Up to Approximately 2 Years

    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.

  4. Overall survival (OS)

    Time frame: Up to Approximately 2 Years

    Defined as the time from the participant's first dose of study drug until death from any cause.

  5. Antidrug Antibody (ADA)

    Time frame: Up to Approximately 2 Years

    Incidence and concentration of anti-drug antibodies.

  6. Neutralizing Antidrug Antibody (nADA)

    Time frame: Up to Approximately 2 Years

    Incidence and concentration of neutralizing anti-drug antibodies.

Sponsors and collaborators

Lead sponsor

AbbVie

Industry

Registry information

Official study title

A Phase 1b Study to Evaluate the Safety and Pharmacokinetics of Livmoniplimab in Combination With Budigalimab in Chinese Subjects With Locally Advanced or Metastatic Child-Pugh A Hepatocellular Carcinoma Who Have Progressed After a First-Line Regimen That Includes an Immune Checkpoint Inhibitor

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Jul 5, 2024
Registry last updated
Aug 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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