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RECRUITING
NCT06858813
PHASE1

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)

Sponsor: AbbVie

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

232

Start Date

2025-04-14

Completion Date

2030-09

Last Updated

2026-03-25

Healthy Volunteers

No

Interventions

DRUG

Lenvatinib

Oral Capsule

DRUG

ABBV-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