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)
Public ClinicalTrials.gov record NCT06858813. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase 1 First-in-Human Study Evaluating Safety, Pharmacokinetics and Efficacy of ABBV 324 in Adults With Hepatocellular Cancer or Squamous Cell Non-Small Cell Lung Cancer
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT06858813
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Phase 1
- Enrollment
- 232 participants
Conditions and interventions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Apr 13, 2025
- Primary completion
- Aug 31, 2030
- Completion
- Aug 31, 2030
- Last update posted
- Mar 24, 2026
2025 – 2030
United States locations
- U.S. sites
- 10
- U.S. states
- 6
- U.S. cities
- 10
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| City of Hope National Medical Center /ID# 270526 | Duarte | California | 91010 | Recruiting |
| City of Hope - Orange County Lennar Foundation Cancer Center /ID# 276120 | Irvine | California | 92618 | Recruiting |
| USC Norris Comprehensive Cancer Center /ID# 271573 | Los Angeles | California | 90033 | Recruiting |
| UC Irvine Medical Center /ID# 270507 | Orange | California | 92868-3201 | Recruiting |
| UCLA - Santa Monica /ID# 275995 | Santa Monica | California | 90404 | Recruiting |
| University of Chicago Medical Center /ID# 270517 | Chicago | Illinois | 60637 | Recruiting |
| Washington University /ID# 275757 | St Louis | Missouri | 63110 | Recruiting |
| Memorial Sloan Kettering Cancer Center /ID# 271228 | New York | New York | 10021-3459 | Recruiting |
| Thomas Jefferson University Sidney Kimmel Cancer Center /ID# 276269 | Philadelphia | Pennsylvania | 19107 | Recruiting |
| SCRI Oncology Partners /ID# 272750 | Nashville | Tennessee | 37203 | Recruiting |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 12 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT06858813, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Mar 24, 2026 · Synced Sep 1, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT06858813 live on ClinicalTrials.gov.