Actively Recruiting
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)
Led by AbbVie · Updated on 2026-03-25
232
Participants Needed
22
Research Sites
280 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
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)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- For hepatocellular cancer (HCC) only: Child-Pugh A classification within 7 days before Cycle 1, Day 1 dosing.
- Laboratory values meeting the criteria outlined in the protocol.
- QT interval corrected for heart rate (QTc) less than 470 msec, no Grade 3 arrhythmia, and no other clinically significant cardiac abnormalities.
- Measurable disease per RECIST version 1.1.
- For HCC participants: locally advanced, metastatic, or unresectable disease confirmed by histology or cytology; not amenable to surgery or locoregional therapies, or progressive disease after such therapies.
- For HCC participants in Part 1: failure of at least 1 prior systemic treatment.
- For HCC participants in Part 2: failure of at least 1 prior systemic treatment including an immune checkpoint inhibitor regimen; prior lenvatinib treatment excludes eligibility.
- For LUSC participants in Part 1 only: advanced or metastatic disease not suitable for surgical resection.
- For LUSC participants: failed at least 1 prior therapy including platinum-based chemotherapy and an immune checkpoint inhibitor, or unsuitable for other approved therapies; no more than 2 prior lines of cytotoxic chemotherapy excluding neoadjuvant/adjuvant; intolerance to standard therapy allowed.
You will not qualify if you...
- Unresolved clinically significant adverse events greater than Grade 1 from prior anticancer therapy except alopecia.
- Untreated brain or meningeal metastases; those with history must be stable without steroid treatment for at least 14 days.
- History of interstitial lung disease or pneumonitis requiring systemic steroids, or active disease on chest CT scan.
- History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, or idiopathic pneumonitis.
- History of significant lung illnesses including recent pulmonary emboli, severe asthma, severe COPD, restrictive lung disease, pleural effusion, or oxygen dependence.
- Any autoimmune, connective tissue, or inflammatory disorders with possible lung involvement at screening.
- Anticancer therapy with antineoplastic intent must be discontinued within 14 days or 5 half-lives (whichever is shorter) before first ABBV-324 dose; limited palliative radiation allowed without washout.
AI-Screening
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Trial Site Locations
Total: 22 locations
1
City of Hope National Medical Center /ID# 270526
Duarte, California, United States, 91010
Actively Recruiting
2
City of Hope - Orange County Lennar Foundation Cancer Center /ID# 276120
Irvine, California, United States, 92618
Actively Recruiting
3
USC Norris Comprehensive Cancer Center /ID# 271573
Los Angeles, California, United States, 90033
Actively Recruiting
4
UC Irvine Medical Center /ID# 270507
Orange, California, United States, 92868-3201
Actively Recruiting
5
UCLA - Santa Monica /ID# 275995
Santa Monica, California, United States, 90404
Actively Recruiting
6
University of Chicago Medical Center /ID# 270517
Chicago, Illinois, United States, 60637
Actively Recruiting
7
Washington University /ID# 275757
St Louis, Missouri, United States, 63110
Actively Recruiting
8
Memorial Sloan Kettering Cancer Center /ID# 271228
New York, New York, United States, 10021-3459
Actively Recruiting
9
Thomas Jefferson University Sidney Kimmel Cancer Center /ID# 276269
Philadelphia, Pennsylvania, United States, 19107
Actively Recruiting
10
SCRI Oncology Partners /ID# 272750
Nashville, Tennessee, United States, 37203
Actively Recruiting
11
Nanfang Hospital - Southern Medical University /ID# 276916
Guangzhou, Guangdong, China, 510000
Actively Recruiting
12
Zhongshan Hospital Fudan University /ID# 276917
Shanghai, Shanghai Municipality, China, 200032
Actively Recruiting
13
Rambam Health Care Campus /ID# 270604
Haifa, Israel, 3109601
Actively Recruiting
14
Hadassah Medical Center-Hebrew University /ID# 271235
Jerusalem, Israel, 91120
Actively Recruiting
15
Rabin Medical Center. /ID# 271236
Petah Tikva, Israel, 4941492
Actively Recruiting
16
National Cancer Center Hospital East /ID# 270585
Kashiwa-shi, Chiba, Japan, 277-8577
Actively Recruiting
17
Kansai Medical University Hospital /ID# 272884
Hirakata-shi, Osaka, Japan, 573-1191
Actively Recruiting
18
National Cancer Center Hospital /ID# 270583
Chuo-Ku, Tokyo, Japan, 104-0045
Actively Recruiting
19
Fdi Clinical Research /ID# 272960
San Juan, Puerto Rico, 00927
Completed
20
Hospital Universitario Fundacion Jimenez Diaz /ID# 272718
Madrid, Spain, 28040
Actively Recruiting
21
Hospital Universitario HM Sanchinarro /ID# 272719
Madrid, Spain, 28050
Actively Recruiting
22
National Taiwan University Hospital /ID# 270593
Taipei, Taiwan, 100
Actively Recruiting
Research Team
A
ABBVIE CALL CENTER
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
5
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