Livmoniplimab
DrugIntravenous infusion
Other names: ABBV-151
NCT Number: NCT06487559
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Phase 1
Beijing Youan Hospital, Capital Medical University -No differernce with previous /ID# 261928, Beijing, Beijing Municipality, China
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Intravenous infusion
Other names: ABBV-151
Intravenous infusion
Other names: ABBV-181
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.
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.
Time frame: Up to Approximately 2 Years
Maximum Plasma Concentration (Cmax) of livmoniplimab and Budigalimab
Time frame: Up to Approximately 2 Years
AUC of livmoniplimab and Budigalimab
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.
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.
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.
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.
Time frame: Up to Approximately 2 Years
Incidence and concentration of anti-drug antibodies.
Time frame: Up to Approximately 2 Years
Incidence and concentration of neutralizing anti-drug antibodies.
Contact information is provided by the study sponsor or research team.
AbbVie
Industry
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
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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