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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)
NCT06858813 · View on ClinicalTrials.gov ↗
Study Summary
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.
Conditions Studied
Interventions
- DRUG Lenvatinib
- DRUG ABBV-324
Study Locations (20)
California
- City of Hope National Medical Center /ID# 270526 — Duarte
- City of Hope - Orange County Lennar Foundation Cancer Center /ID# 276120 — Irvine
- USC Norris Comprehensive Cancer Center /ID# 271573 — Los Angeles
- UC Irvine Medical Center /ID# 270507 — Orange
- UCLA - Santa Monica /ID# 275995 — Santa Monica
Other
- Rambam Health Care Campus /ID# 270604 — Haifa
- Hadassah Medical Center-Hebrew University /ID# 271235 — Jerusalem
- Rabin Medical Center /ID# 271236 — Petah Tikva
- Fdi Clinical Research /ID# 272960 — San Juan
- Hospital Universitario Fundación Jiménez Díaz /ID# 272718 — Madrid
Illinois
- University of Chicago Medical Center /ID# 270517 — Chicago
Missouri
- Washington University /ID# 275757 — St Louis
New York
- Memorial Sloan Kettering Cancer Center /ID# 271228 — New York
Pennsylvania
- Thomas Jefferson University Sidney Kimmel Cancer Center /ID# 276269 — Philadelphia
Tennessee
- SCRI Oncology Partners /ID# 272750 — Nashville
Guangdong
- Nanfang Hospital - Southern Medical University /ID# 276916 — Guangzhou
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 232 participants |
| Start Date | 2025-04-14 |
| Est. Completion | 2030-09 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06858813
The ClinicalTrials.gov registry entry for NCT06858813 describes a study currently listed as recruiting. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 232 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is AbbVie, which has 603 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 2 conditions, with Hepatocellular Cancer appearing as the primary indexed condition, and to 2 interventions — of which Lenvatinib is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT06858813 reports 20 study locations spanning 12 distinct geographic areas — top geographies include California, Other, Illinois. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT06858813 about?
NCT06858813 is a clinical study titled "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)". 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...
What is the current status of trial NCT06858813?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 232 participants. The study started on 2025-04-14. Estimated completion is 2030-09.
What conditions does trial NCT06858813 study?
This clinical trial studies the following conditions: Hepatocellular Cancer, Squamous-Cell Non-Small Cell Lung Cancer. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06858813?
The interventions under investigation include: Lenvatinib (DRUG), ABBV-324 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06858813?
This trial is sponsored by AbbVie, which has 603 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT06858813 being conducted?
This trial has 20 study locations across California, Illinois, Missouri, New York, Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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