AzTrials
AzTrials

Hepatocellular Carcinoma (HCC)Phase 1NCT06487559

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)

A Phase 1 study testing Livmoniplimab and Budigalimab in people with Hepatocellular Carcinoma (HCC), run by AbbVie at 11 sites in China.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Hepatocellular Carcinoma (HCC)
What is being tested?
Livmoniplimab and Budigalimab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
3 participants
Where
11 sitesChina
Study dates
11 Sep 2024to 18 Sep 2026
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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.

Trial locations and contacts

11 sites in 1 country.

11 sites in 1 country

China11 sites

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

    Beijing, Beijing Municipality, 100069

  • Mengchao Hepatobiliary Hospital of Fujian Medical University /ID# 262443

    Fuzhou, Fujian, 350012

  • Sun Yat-Sen University Cancer Center /ID# 262092

    Guangzhou, Guangdong, 510060

  • Nanfang Hospital of Southern Medical University /ID# 262091

    Guangzhou, Guangdong, 510515

  • Zhejiang Cancer hospital /ID# 262046

    Hangzhou, Zhejiang, 310022

  • Harbin Medical University Cancer Hospital /Id# 262070

    Harbin, Heilongjiang, 150081

  • The Second Affiliated Hospital of Nanchang University /ID# 262085

    Nanchang, Jiangxi, 330008

  • Zhongshan Hospital Fudan University /ID# 262135

    Shanghai, Shanghai Municipality, 200032

  • Liaoning Cancer Hospital & Institute /ID# 268023

    Shenyang, Liaoning, 110042

  • Hubei Cancer Hospital /ID# 262030

    Wuhan, Hubei, 430079

  • Henan Cancer Hospital /ID# 262098

    Zhengzhou, Henan, 450008

Other trials in China

About this study

Official 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

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.

Read more

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.

Being tested
Livmoniplimab, Budigalimab
Keywords
Hepatocellular Carcinoma (HCC), Livmoniplimab, ABBV-151, budigalimab, ABBV-181
Medical subject headings
Carcinoma, Hepatocellular

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LivmoniplimabDrug

    Also called ABBV-151

    Intravenous infusion

  • BudigalimabDrug

    Also called ABBV-181

    Intravenous infusion

Study groups in NCT06487559
Study groupRoleWhat they receive
Stage 1: Cohort 1 Livmoniplimab + Budigalimab Dose AExperimentalParticipants will receive livmoniplimab Dose A in combination with budigalimab every 3 weeks for approximately 2 years.
Receives: Drug: Livmoniplimab; Drug: Budigalimab
Stage 2: Cohort 2 Livmoniplimab + Budigalimab Dose BExperimentalParticipants will receive livmoniplimab Dose B in combination with budigalimab every 3 weeks for approximately 2 years.
Receives: Drug: Livmoniplimab; Drug: Budigalimab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Up to Approximately 2 Years

  2. 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.

    Measured: Up to Approximately 2 Years

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

    Maximum Plasma Concentration (Cmax) of livmoniplimab and Budigalimab

    Measured: Up to Approximately 2 Years

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

    AUC of livmoniplimab and Budigalimab

    Measured: Up to Approximately 2 Years

Secondary outcomes (6)

  1. 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.

    Measured: Up to Approximately 2 Years

  2. 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.

    Measured: Up to Approximately 2 Years

  3. 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.

    Measured: Up to Approximately 2 Years

  4. Overall survival (OS)

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

    Measured: Up to Approximately 2 Years

  5. Antidrug Antibody (ADA)

    Incidence and concentration of anti-drug antibodies.

    Measured: Up to Approximately 2 Years

  6. Neutralizing Antidrug Antibody (nADA)

    Incidence and concentration of neutralizing anti-drug antibodies.

    Measured: Up to Approximately 2 Years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Jul 2024
  2. Study start11 Sep 2024
  3. Primary completion18 Sep 2026
  4. Study completion18 Sep 2026

Why it stopped: Strategic considerations

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
3 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06487559
Sponsor's protocol ID
M24-695
Status last verified
Oct 2026
First submitted
28 Jun 2024
Last updated
21 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Livmoniplimab and Budigalimab in people with Hepatocellular Carcinoma (HCC), run by AbbVie at 11 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 21 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Strategic considerations). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants With Adverse Events (AE) (time frame: Up to Approximately 2 Years). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06487559.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2026.

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