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)
NCT ID: NCT06858813
Last Updated: 2025-11-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
232 participants
INTERVENTIONAL
2025-04-14
2030-09-30
Brief Summary
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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.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Part 1 Dose Escalation: ABBV-324
Participants will receive escalating doses of ABBV-324 as part of the approximately 6.5 year study duration.
ABBV-324
Intravenous (IV) Infusion
Part 2 Dose Optimization Arm 1: ABBV-324 Dose 1
Participants will receive ABBV-324 dose 1 as part of the approximately 6.5 year study duration.
ABBV-324
Intravenous (IV) Infusion
Part 2 Dose Optimization Arm 1: ABBV-324 Dose 2
Participants will receive ABBV-324 dose 2 as part of the approximately 6.5 year study duration.
ABBV-324
Intravenous (IV) Infusion
Part 2 Dose Optimization Arm 1: ABBV-324 Dose 3
Participants will receive ABBV-324 dose 3 as part of the approximately 6.5 year study duration.
ABBV-324
Intravenous (IV) Infusion
Part 2 Comparator Arm 4: Lenvatinib
Participants will receive lenvatinib as part of the approximately 6.5 year study duration.
Lenvatinib
Oral Capsule
Interventions
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Lenvatinib
Oral Capsule
ABBV-324
Intravenous (IV) Infusion
Eligibility Criteria
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Inclusion Criteria
* 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) \< 470 msec (using Fridericia's correction), no Grade 3 arrythmia, and no other clinically significant cardiac abnormalities.
* Measurable disease per RECIST version 1.1.
* Part 1 and Part 2 - participants with HCC meeting the following disease activity criteria:
* Locally advanced or metastatic and/or unresectable HCC with diagnosis confirmed by histology or cytology. Participants with fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma/HCC are not eligible to enroll.
* Disease that is not amenable to surgical and/or locoregional therapies, or progressive disease after surgical and/or locoregional therapies. For participants who progressed after locoregional therapy for HCC, locoregional therapy must have been completed \>= 28 days prior to baseline scan for the current study.
* Part 1: Failure of at least 1 prior systemic treatment for HCC.
* Part 2: Failure of at least 1 prior systemic treatment consisting of an immune checkpoint inhibitor (CPI) containing regimen for HCC, including but not limited to, atezolizumab in combination with bevacizumab or tremelimumab in combination with durvalumab. Note: Participants who have received prior lenvatinib will not be eligible for Part 2.
* Part 1 only - participants with squamous-cell non-small cell lung cancer (LUSC) meeting the following disease activity criteria:
* Advanced or metastatic LUSC that is not amenable to surgical resection.
* Must have failed at least 1 prior line of therapy that included at least platinum-based chemotherapy and an immune CPI, and/or an appropriate targeted therapy (if applicable), or is not suitable for other approved therapeutic options that have demonstrated clinical benefit at the judgment of the investigator. Participants should have no more than 2 lines of prior cytotoxic chemotherapy excluding neoadjuvant and/or adjuvant. Participants who are intolerant of standard therapy are eligible.
Exclusion Criteria
* Untreated brain or meningeal metastases (i.e., participants with history of metastases are eligible provided they do not require ongoing steroid treatment for cerebral edema and have shown clinical and radiographic stability for at least 14 days after definitive therapy). Participants may continue with antiepileptic therapy if required.
* History of interstitial lung disease (ILD) or pneumonitis that required treatment with systemic steroids, nor any evidence of active ILD or pneumonitis on screening chest computed tomography (CT) scan.
* History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis.
* History of clinically significant, intercurrent lung-specific illnesses including, but not limited to:
* Underlying pulmonary disorder (i.e., pulmonary emboli within 3 months of the study enrollment, severe asthma, severe COPD, restrictive lung disease, pleural effusion, dependence on supplemental oxygen, etc.).
* Any autoimmune, connective tissue or inflammatory disorders with documented or suspicious pulmonary involvement at Screening.
* Must have discontinued anticancer therapy with antineoplastic intent including chemotherapy, radiation therapy, immunotherapy, biologic, or any investigational therapy within 14 days or 5 half lives of the drug (whichever is shorter) prior to the first dose of ABBV-324. Palliative radiation therapy for bone, skin or subcutaneous metastases with 10 fractions or less is permitted and not participant to a washout period.
18 Years
ALL
No
Sponsors
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AbbVie
INDUSTRY
Responsible Party
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Principal Investigators
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ABBVIE INC.
Role: STUDY_DIRECTOR
AbbVie
Locations
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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 /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 Fundación Jiménez Díaz /ID# 272718
Madrid, , Spain
Hospital Universitario HM Sanchinarro /ID# 272719
Madrid, , Spain
Countries
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Central Contacts
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Related Links
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Other Identifiers
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2024-518012-39
Identifier Type: OTHER
Identifier Source: secondary_id
M25-292
Identifier Type: -
Identifier Source: org_study_id