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A Study of ABBV-324 for Liver or Lung Cancer

This study is looking at an investigational drug called ABBV-324 for adults with hepatocellular cancer (HCC), a type of liver cancer, or squamous-cell non-small cell lung cancer (LUSC), a type of lung cancer. Researchers want to understand any side effects (adverse events) and how ABBV-324 affects the cancer. You would receive ABBV-324, either alone or compared to another drug called Lenvatinib. The study aims to enroll about 232 participants worldwide. To join, you must be at least 18 years old, have a good general health status (ECOG performance status of 0 or 1), and meet specific lab test criteria, including for liver function if you have HCC.

Study design
This is an interventional study involving approximately 232 participants. Participants will be placed into groups (arms) to receive either ABBV-324 alone or Lenvatinib.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for adverse events, changes in vital signs, and changes in electrocardiograms (ECG) for up to approximately 4 years.

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NCT06858813

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)

Recruiting
PHASE1Ages 18+InterventionalTreatment
AbbVie
~232 participants
Updated 2026-03-25 on ClinicalTrials.gov
What's tested:LenvatinibABBV-324

At a glance

Recruiting sites
21 of 22 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of Participants with Adverse Events (AE)s
Measured over Up to Approximately 4 Years
+4 more outcomes measured

Conditions

Hepatocellular Cancer
Squamous-Cell Non-Small Cell Lung Cancer

Explore related trials

Lung Non-Small Cell CarcinomaMalignant Liver Neoplasm

Where it's being run

22 sites across 15 states
California5
Israel3
Spain2
Illinois1
Missouri1
New York1
Pennsylvania1
Tennessee1

Study leadership

  • ABBVIE INC. · STUDY_DIRECTOR · AbbVie

Who to contact

ABBVIE CALL CENTER
[email protected]
844-663-3742
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
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

Unresolved clinically significant adverse events (AEs) \> Grade 1 from prior anticancer therapy except for alopecia.
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, or 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.

What this trial measures

  • Number of Participants with Adverse Events (AE)sUp to Approximately 4 Years

    An adverse event is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment.

  • Number of Participants with Change in Vital SignsUp to Approximately 4 Years

    Number of Participants with Change in Vital Signs will be assessed.

  • Number of Participants with Change in Electrocardiogram (ECG)Up to Approximately 4 Years

    Number of Participants with Change in ECG will be assessed.

  • Number of Participants with Change in Clinical Laboratory TestsUp to Approximately 4 Years

    Number of participants with change in clinical laboratory tests will be assessed.

  • Objective Response Rate (ORR)Up to Approximately 4 Years

    ORR is defined as the percentage of participants with a confirmed Complete Response or partial response(PR) per investigator review according to response evaluation criteria in solid tumors (RECIST) version 1.1.