RecruitingPhase 1NCT06858813

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 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

Sponsor

AbbVie

Enrollment

232 participants

Start Date

Apr 14, 2025

Study Type

INTERVENTIONAL

Conditions

Hepatocellular Cancer

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This early-phase study is testing a new experimental drug called ABBV-324 — given through an IV infusion — in patients with either advanced liver cancer (hepatocellular carcinoma, HCC) or squamous-cell lung cancer (LUSC) that has progressed on prior treatments. **You may be eligible if...** - You have advanced, unresectable hepatocellular carcinoma (liver cancer) with prior systemic treatment history, OR squamous-cell non-small cell lung cancer with prior treatment - Your general health score (ECOG) is 0 or 1 - Your heart rhythm, liver function, and lab values meet required thresholds - You have measurable disease on imaging **You may NOT be eligible if...** - You have unresolved significant side effects from prior cancer treatment - You have untreated brain metastases - You have a history of interstitial lung disease or pneumonitis that required steroids - You have fibrolamellar, sarcomatoid, or mixed HCC/cholangiocarcinoma liver cancer (for the HCC group) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGLenvatinib

Oral Capsule

DRUGABBV-324

Intravenous (IV) Infusion

Locations(22)

City of Hope National Medical Center /ID# 270526

Duarte, California, United States

City of Hope - Orange County Lennar Foundation Cancer Center /ID# 276120

Irvine, California, United States

USC Norris Comprehensive Cancer Center /ID# 271573

Los Angeles, California, United States

UC Irvine Medical Center /ID# 270507

Orange, California, United States

UCLA - Santa Monica /ID# 275995

Santa Monica, California, United States

University of Chicago Medical Center /ID# 270517

Chicago, Illinois, United States

Washington University /ID# 275757

St Louis, Missouri, United States

Memorial Sloan Kettering Cancer Center /ID# 271228

New York, New York, United States

Thomas Jefferson University Sidney Kimmel Cancer Center /ID# 276269

Philadelphia, Pennsylvania, United States

SCRI Oncology Partners /ID# 272750

Nashville, Tennessee, United States

Nanfang Hospital - Southern Medical University /ID# 276916

Guangzhou, Guangdong, China

Zhongshan Hospital Fudan University /ID# 276917

Shanghai, Shanghai Municipality, China

Rambam Health Care Campus /ID# 270604

Haifa, Israel

Hadassah Medical Center-Hebrew University /ID# 271235

Jerusalem, Israel

Rabin Medical Center. /ID# 271236

Petah Tikva, Israel

National Cancer Center Hospital East /ID# 270585

Kashiwa-shi, Chiba, Japan

Kansai Medical University Hospital /ID# 272884

Hirakata-shi, Osaka, Japan

National Cancer Center Hospital /ID# 270583

Chuo-Ku, Tokyo, Japan

Fdi Clinical Research /ID# 272960

San Juan, Puerto Rico

Hospital Universitario Fundacion Jimenez Diaz /ID# 272718

Madrid, Spain

Hospital Universitario HM Sanchinarro /ID# 272719

Madrid, Spain

National Taiwan University Hospital /ID# 270593

Taipei, Taiwan

View Full Details on ClinicalTrials.gov

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