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NCT06858813 · ClinicalTrials.gov registry record · Phase 1

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)

A Phase 1 study of Hepatocellular Cancer and Squamous-Cell Non-Small Cell Lung Cancer, sponsored by AbbVie.

Recruiting
Registry status
Phase 1
Development phase
232
Enrollment target
20
Study locations

NCT06858813 is a Phase 1 study of Hepatocellular Cancer and Squamous-Cell Non-Small Cell Lung Cancer that is actively recruiting participants, run by AbbVie. The registered enrollment target is 232 participants, below the 969-participant average among 15 other Hepatocellular Cancer trials with a reported enrollment target (76% lower). The trial reports 20 study locations across 12 states.

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The verdict

NCT06858813, a Phase 1 study of Hepatocellular Cancer and Squamous-Cell Non-Small Cell Lung Cancer, is actively recruiting participants, sponsored by AbbVie.

RECRUITING
Registry status
Phase 1
Development phase
232 participants
Enrollment target
20
Study locations

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

Hepatocellular Cancer Squamous-Cell Non-Small Cell Lung Cancer

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

FieldValue
Enrollment Target 232 participants
Start Date 2025-04-14
Est. Completion 2030-09
Phase Phase 1

Sponsor

AbbVie

526 total trials

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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, categorized as Phase 1. The registered enrollment target is 232 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 969-participant average among 15 other Hepatocellular Cancer trials with a reported enrollment target (76% lower). The listed sponsor is AbbVie, which has 526 total studies on file at ClinicalTrials.gov.

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.

NCT06858813 reports 20 study locations spanning 12 distinct geographic areas - top geographies include California, Other, Illinois.

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.

What interventions are being tested in trial NCT06858813?

The interventions under investigation include: Lenvatinib (DRUG), ABBV-324 (DRUG).

Who is sponsoring clinical trial NCT06858813?

This trial is sponsored by AbbVie, which has 526 total clinical trials registered on ClinicalTrials.gov.

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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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.