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.
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
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
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.
- Conditions
- Hepatocellular Carcinoma (HCC)
- 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 group | Role | What they receive |
|---|---|---|
| Stage 1: Cohort 1 Livmoniplimab + Budigalimab Dose A | Experimental | Participants 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 B | Experimental | Participants 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.
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
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
Maximum Plasma Concentration (Cmax) of Livmoniplimab and Budigalimab
Maximum Plasma Concentration (Cmax) of livmoniplimab and Budigalimab
Measured: Up to Approximately 2 Years
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)
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
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
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
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
Antidrug Antibody (ADA)
Incidence and concentration of anti-drug antibodies.
Measured: Up to Approximately 2 Years
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.
- First posted5 Jul 2024
- Study start11 Sep 2024
- Primary completion18 Sep 2026
- Study completion18 Sep 2026
Why it stopped: Strategic considerations
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatocellular Carcinoma (HCC)Studies of the same condition, open and under way.
- More trials run by AbbVieThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- AbbVie
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- ABBVIE INC., Study director, AbbVie
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