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New cancer drug ABBV-324 enters first human trials

NCT ID NCT06858813

Disease control Sponsor: AbbVie Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This early-stage trial tests an investigational drug called ABBV-324 in about 232 adults with liver cancer (hepatocellular carcinoma) or a type of lung cancer (squamous-cell non-small cell lung cancer). Some participants receive ABBV-324 alone, while others get a standard drug called lenvatinib. The main goals are to check safety and see if tumors shrink. The study will run for about 6.5 years.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
ABBV-324 (intravenous infusion) and lenvatinib (oral capsule)
What this could lead to
If successful, this could point toward a new treatment option for advanced liver or lung cancer.
What could go wrong
This is an early Phase 1 trial, so the drug may not work or could cause unexpected side effects. It will take years to complete.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 232 people

The number the study aims to enrol. It can still change while the study runs.

Started

Apr 2025

Expected to finish

Sep 2030

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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 Criteria: * 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.

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Conditions

The condition(s) this trial relates to.

hepatocellular carcinoma Liver Neoplasms non-small cell squamous lung carcinoma pediatric hepatocellular carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Hepatocellular cancer Squamous cell non small cell lung cancer

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    21 sites in 6 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • City of Hope - Orange County Lennar Foundation Cancer Center /ID# 276120

    RECRUITING

    Irvine, California, 92618, United States

  • City of Hope National Medical Center /ID# 270526

    RECRUITING

    Duarte, California, 91010, United States

  • Fdi Clinical Research /ID# 272960

    COMPLETED

    San Juan, 00927, Puerto Rico

  • Hadassah Medical Center-Hebrew University /ID# 271235

    RECRUITING

    Jerusalem, 91120, Israel

  • Hospital Universitario Fundacion Jimenez Diaz /ID# 272718

    RECRUITING

    Madrid, 28040, Spain

  • Hospital Universitario HM Sanchinarro /ID# 272719

    RECRUITING

    Madrid, 28050, Spain

  • Kansai Medical University Hospital /ID# 272884

    RECRUITING

    Hirakata-shi, Osaka, 573-1191, Japan

  • Memorial Sloan Kettering Cancer Center /ID# 271228

    RECRUITING

    New York, New York, 10021-3459, United States

  • Nanfang Hospital - Southern Medical University /ID# 276916

    RECRUITING

    Guangzhou, Guangdong, 510000, China

  • National Cancer Center Hospital /ID# 270583

    RECRUITING

    Chuo-Ku, Tokyo, 104-0045, Japan

  • National Cancer Center Hospital East /ID# 270585

    RECRUITING

    Kashiwa-shi, Chiba, 277-8577, Japan

  • National Taiwan University Hospital /ID# 270593

    RECRUITING

    Taipei, 100, Taiwan

  • Rabin Medical Center. /ID# 271236

    RECRUITING

    Petah Tikva, 4941492, Israel

  • Rambam Health Care Campus /ID# 270604

    RECRUITING

    Haifa, 3109601, Israel

  • SCRI Oncology Partners /ID# 272750

    RECRUITING

    Nashville, Tennessee, 37203, United States

  • Thomas Jefferson University Sidney Kimmel Cancer Center /ID# 276269

    RECRUITING

    Philadelphia, Pennsylvania, 19107, United States

  • UC Irvine Medical Center /ID# 270507

    RECRUITING

    Orange, California, 92868-3201, United States

  • UCLA - Santa Monica /ID# 275995

    RECRUITING

    Santa Monica, California, 90404, United States

  • USC Norris Comprehensive Cancer Center /ID# 271573

    RECRUITING

    Los Angeles, California, 90033, United States

  • University of Chicago Medical Center /ID# 270517

    RECRUITING

    Chicago, Illinois, 60637, United States

  • Washington University /ID# 275757

    RECRUITING

    St Louis, Missouri, 63110, United States

  • Zhongshan Hospital Fudan University /ID# 276917

    RECRUITING

    Shanghai, Shanghai Municipality, 200032, China

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