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Study identifier: NCT06858813 Synced from ClinicalTrials.gov · July 28, 2026
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A Study to Assess Adverse Events and Change in Disease Activity of Intravenously (IV) Infused ABBV-324 in Adult Participants With Hepatocellular Cancer (HCC) or Squamous-Cell Non-Small Cell Lung Cancer (LUSC)

Condition: Hepatocellular Cancer · Squamous-Cell Non-Small Cell Lung Cancer  ·  Sponsor: AbbVie

PhasePhase 1
Planned participants232
Who can joinAll sexes, 18 Years to no upper limit
Healthy volunteersNo

About this study

HCC is a common cancer worldwide and a leading cause of cancer-related death. Lung cancer is the most frequently diagnosed cancer in the world, and the leading cause of cancer deaths. The purpose of this study is to assess adverse events and change in disease activity when ABBV-324 is given to adult participants to treat hepatocellular cancer (HCC) or squamous-cell non-small cell lung cancer (LUSC). ABBV-324 is an investigational drug being developed for the treatment of HCC and LUSC. Study doctors put the participants in groups called arms. Each arm receives ABBV-324 alone (monotherapy) or a comparator drug, lenvatinib followed by a safety follow-up period. Approximately 232 HCC or LUSC will be enrolled in the study in approximately 45 sites worldwide. In the dose escalation stage participants will be treated with increasing intravenous (IV) doses of ABBV-324 until the dose reached is tolerable and expected to be efficacious. In the dose optimization stage participants will receive ABBV-324, or a comparator of oral lenvatinib. The study will run for a duration of approximately 6.5 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 an approved institution (hospital or clinic). The effect of the treatment will be frequently checked by medical assessments, blood tests, questionnaires and side effects.

This description comes directly from the study's public registry record.

Talk to the study team

ABBVIE CALL CENTER  ·  844-663-3742  ·  abbvieclinicaltrials@abbvie.com

Always discuss trial participation with your own doctor first.

Locations (22)

City of Hope National Medical Center /ID# 270526Duarte, California, United StatesRecruiting
City of Hope - Orange County Lennar Foundation Cancer Center /ID# 276120Irvine, California, United StatesRecruiting
USC Norris Comprehensive Cancer Center /ID# 271573Los Angeles, California, United StatesRecruiting
UC Irvine Medical Center /ID# 270507Orange, California, United StatesRecruiting
UCLA - Santa Monica /ID# 275995Santa Monica, California, United StatesRecruiting
University of Chicago Medical Center /ID# 270517Chicago, Illinois, United StatesRecruiting
Washington University /ID# 275757St Louis, Missouri, United StatesRecruiting
Memorial Sloan Kettering Cancer Center /ID# 271228New York, New York, United StatesRecruiting
Thomas Jefferson University Sidney Kimmel Cancer Center /ID# 276269Philadelphia, Pennsylvania, United StatesRecruiting
SCRI Oncology Partners /ID# 272750Nashville, Tennessee, United StatesRecruiting
Nanfang Hospital - Southern Medical University /ID# 276916Guangzhou, Guangdong, ChinaRecruiting
Zhongshan Hospital Fudan University /ID# 276917Shanghai, Shanghai Municipality, ChinaRecruiting

+ 10 more locations — full list on the registry record.

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Source record: clinicaltrials.gov/study/NCT06858813