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)
Start Date
4/14/2025
Completion Date
9/1/2030
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 Criteria
Age Range: 18 years to No maximum
Interventions
Lenvatinib
ABBV-324
Conditions
Locations
City of Hope National Medical Center /ID# 270526
Duarte, California 91010
United States
City of Hope - Orange County Lennar Foundation Cancer Center /ID# 276120
Irvine, California 92618
United States
USC Norris Comprehensive Cancer Center /ID# 271573
Los Angeles, California 90033
United States
UC Irvine Medical Center /ID# 270507
Orange, California 92868-3201
United States
UCLA - Santa Monica /ID# 275995
Santa Monica, California 90404
United States
University of Chicago Medical Center /ID# 270517
Chicago, Illinois 60637
United States
Washington University /ID# 275757
St Louis, Missouri 63110
United States
Memorial Sloan Kettering Cancer Center /ID# 271228
New York, New York 10021-3459
United States
Thomas Jefferson University Sidney Kimmel Cancer Center /ID# 276269
Philadelphia, Pennsylvania 19107
United States
SCRI Oncology Partners /ID# 272750
Nashville, Tennessee 37203
United States
Nanfang Hospital - Southern Medical University /ID# 276916
Guangzhou, Guangdong 510000
China
Zhongshan Hospital Fudan University /ID# 276917
Shanghai, Shanghai Municipality 200032
China
Rambam Health Care Campus /ID# 270604
Haifa, 3109601
Israel
Hadassah Medical Center-Hebrew University /ID# 271235
Jerusalem, 91120
Israel
Rabin Medical Center. /ID# 271236
Petah Tikva, 4941492
Israel
National Cancer Center Hospital East /ID# 270585
Kashiwa-shi, Chiba 277-8577
Japan
Kansai Medical University Hospital /ID# 272884
Hirakata-shi, Osaka 573-1191
Japan
National Cancer Center Hospital /ID# 270583
Chuo-Ku, Tokyo 104-0045
Japan
Fdi Clinical Research /ID# 272960
San Juan, 00927
Puerto Rico
Hospital Universitario Fundacion Jimenez Diaz /ID# 272718
Madrid, 28040
Spain
Hospital Universitario HM Sanchinarro /ID# 272719
Madrid, 28050
Spain
National Taiwan University Hospital /ID# 270593
Taipei, 100
Taiwan