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)
This is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.
About the trial
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.
Original English text from ClinicalTrials.gov
Who can (and can't) join
✓ Qualifies
- •Ogólny stan zdrowia pacjenta oceniany na 0 lub 1 w skali wydolności
- •Dla raka wątroby: klasyfikacja wątroby Child-Pugh A wykonana w ciągu 7 dni przed leczeniem
- •Wyniki badań laboratoryjnych zgodne z wymogami badania
- •Prawidłowa czynność serca (QTc poniżej 470 ms, bez zaburzeń rytmu klasy 3 i innych problemów serca)
- •Rozpoznawalny nowotwór widoczny w badaniach obrazowych
- •Rak wątroby zaawansowany, nieoperacyjny lub przerzutowy
- •Wcześniejszy brak skuteczności leczenia systemowego (dla raka wątroby wymaga immunoterapii)
- •Rak płuca zaawansowany, nieoperacyjny, z wcześniejszym brakiem skuteczności chemioterapii i immunoterapii
✗ Disqualifies
- •Specjalne typy raka wątroby: fibrolamellarny, sarkomatoidalny lub mieszany cholangiocarcinoma/HCC
- •Pacjenci z rakiem wątroby, którzy otrzymali wcześniej lenvatinib (w części 2 badania)
- •Nowotwór możliwy do wyleczenia poprzez operację lub napromienianie
Simplified criteria — AI translation
Trial details
- Minimum age
- 18 Years
- Last updated (source)
- September 22, 2026
- Sex
- No restrictions
Therapies / drugs in trial
Locations (22)
City of Hope National Medical Center /ID# 270526
Duarte, United States
City of Hope - Orange County Lennar Foundation Cancer Center /ID# 276120
Irvine, United States
USC Norris Comprehensive Cancer Center /ID# 271573
Los Angeles, United States
University Of California Irvine Medical Center /ID# 270507
Orange, United States
UCLA - Santa Monica /ID# 275995
Santa Monica, United States
University of Chicago Medical Center /ID# 270517
Chicago, United States
Washington University /ID# 275757
St Louis, United States
Memorial Sloan Kettering Cancer Center /ID# 271228
New York, United States
Thomas Jefferson University Sidney Kimmel Cancer Center /ID# 276269
Philadelphia, United States
SCRI Oncology Partners /ID# 272750
Nashville, United States
Nanfang Hospital - Southern Medical University /ID# 276916
Guangzhou, China
Zhongshan Hospital Fudan University /ID# 276917
Shanghai, China
Rabin Medical Center. /ID# 271236
Petah Tikva, Israel
Rambam Health Care Campus /ID# 270604
Haifa, Israel
Hadassah Medical Center-Hebrew University /ID# 271235
Jerusalem, Israel
National Cancer Center Hospital East /ID# 270585
Kashiwa-shi, Japan
Kansai Medical University Hospital /ID# 272884
Hirakata-shi, Japan
National Cancer Center Hospital /ID# 270583
Chuo-Ku, 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
Trial contact
ABBVIE CALL CENTER
Contact information from ClinicalTrials.gov. Contact in English.
Share this trial
Data from ClinicalTrials.gov. AI-assisted translation, last sync: 9/23/2026.
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