Hepatocellular CancerPhase 1NCT06858813
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)
A Phase 1 study testing Lenvatinib and ABBV-324 in people with Hepatocellular Cancer and Squamous-Cell Non-Small Cell Lung Cancer, run by AbbVie at 22 sites in 7 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatocellular Cancer, Squamous-Cell Non-Small Cell Lung Cancer
- What is being tested?
- Lenvatinib and ABBV-324
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 232 participants
- Where
- 22 sitesin 7 countries
- Study dates
- 14 Apr 2025to Sep 2030
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
Show all 13Show fewer
- 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.
Who cannot join
- 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.
Trial locations and contacts
22 sites in 7 countries. Contact the study team or a site near you to ask about taking part.
22 sites in 7 countries
United States10 sites, 10 recruiting
- Recruiting
University of Chicago Medical Center /ID# 270517
Chicago, Illinois, 60637
- Recruiting
City of Hope National Medical Center /ID# 270526
Duarte, California, 91010
- Recruiting
City of Hope - Orange County Lennar Foundation Cancer Center /ID# 276120
Irvine, California, 92618
- Recruiting
USC Norris Comprehensive Cancer Center /ID# 271573
Los Angeles, California, 90033
- Recruiting
SCRI Oncology Partners /ID# 272750
Nashville, Tennessee, 37203
- Recruiting
Memorial Sloan Kettering Cancer Center /ID# 271228
New York, New York, 10021-3459
- Recruiting
University Of California Irvine Medical Center /ID# 270507
Orange, California, 92868
- Recruiting
Thomas Jefferson University Sidney Kimmel Cancer Center /ID# 276269
Philadelphia, Pennsylvania, 19107
- Recruiting
UCLA - Santa Monica /ID# 275995
Santa Monica, California, 90404
- Recruiting
Washington University /ID# 275757
St Louis, Missouri, 63110
Israel3 sites, 3 recruiting
- Recruiting
Rambam Health Care Campus /ID# 270604
Haifa, 3109601
- Recruiting
Hadassah Medical Center-Hebrew University /ID# 271235
Jerusalem, 91120
- Recruiting
Rabin Medical Center. /ID# 271236
Petah Tikva, Central District, 4941492
Japan3 sites, 3 recruiting
- Recruiting
National Cancer Center Hospital /ID# 270583
Chuo-Ku, Tokyo, 104-0045
- Recruiting
Kansai Medical University Hospital /ID# 272884
Hirakata-shi, Osaka, 573-1191
- Recruiting
National Cancer Center Hospital East /ID# 270585
Kashiwa-shi, Chiba, 277-8577
China2 sites, 2 recruiting
- Recruiting
Nanfang Hospital - Southern Medical University /ID# 276916
Guangzhou, Guangdong, 510000
- Recruiting
Zhongshan Hospital Fudan University /ID# 276917
Shanghai, Shanghai Municipality, 200032
Spain2 sites, 2 recruiting
- Recruiting
Hospital Universitario Fundacion Jimenez Diaz /ID# 272718
Madrid, 28040
- Recruiting
Hospital Universitario HM Sanchinarro /ID# 272719
Madrid, 28050
Puerto Rico1 site
- Completed
Fdi Clinical Research /ID# 272960
San Juan, 00927
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Hospital /ID# 270593
Taipei, 100
About this study
Official title: A Phase 1 First-in-Human Study Evaluating Safety, Pharmacokinetics and Efficacy of ABBV 324 in Adults With Hepatocellular Cancer or Squamous Cell Non-Small Cell Lung Cancer
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.
Read more
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.
- Being tested
- Lenvatinib, ABBV-324
- Keywords
- Hepatocellular Cancer, Squamous-Cell Non-Small Cell Lung Cancer, LUSC, HCC, ABBV-324, Lenvatinib
- Medical subject headings
- Liver Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LenvatinibDrug
Oral Capsule
ABBV-324Drug
Intravenous (IV) Infusion
| Study group | Role | What they receive |
|---|---|---|
| Part 1 Dose Escalation: ABBV-324 | Experimental | Participants will receive escalating doses of ABBV-324 as part of the approximately 6.5 year study duration. Receives: Drug: ABBV-324 |
| Part 2 Dose Optimization Arm 1: ABBV-324 Dose 1 | Experimental | Participants will receive ABBV-324 dose 1 as part of the approximately 6.5 year study duration. Receives: Drug: ABBV-324 |
| Part 2 Dose Optimization Arm 1: ABBV-324 Dose 2 | Experimental | Participants will receive ABBV-324 dose 2 as part of the approximately 6.5 year study duration. Receives: Drug: ABBV-324 |
| Part 2 Dose Optimization Arm 1: ABBV-324 Dose 3 | Experimental | Participants will receive ABBV-324 dose 3 as part of the approximately 6.5 year study duration. Receives: Drug: ABBV-324 |
| Part 2 Comparator Arm 4: Lenvatinib | Active comparator | Participants will receive lenvatinib as part of the approximately 6.5 year study duration. Receives: Drug: Lenvatinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Adverse Events (AE)s
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.
Measured: Up to Approximately 4 Years
Number of Participants with Change in Vital Signs
Number of Participants with Change in Vital Signs will be assessed.
Measured: Up to Approximately 4 Years
Number of Participants with Change in Electrocardiogram (ECG)
Number of Participants with Change in ECG will be assessed.
Measured: Up to Approximately 4 Years
Number of Participants with Change in Clinical Laboratory Tests
Number of participants with change in clinical laboratory tests will be assessed.
Measured: Up to Approximately 4 Years
Objective Response Rate (ORR)
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.
Measured: Up to Approximately 4 Years
Secondary outcomes (6)
Area Under the Serum Concentration Versus Time Curve (AUC) of ABBV-324
AUC of ABBV-324.
Measured: Up to Approximately 4 Years
Maximum Observed Serum Concentration (Cmax) of ABBV-324
Cmax of ABBV-324.
Measured: Up to Approximately 4 Years
Time to Maximum Observed Serum Concentration (Tmax) of ABBV-324
Tmax of ABBV-324.
Measured: Up to Approximately 4 Years
Terminal Elimination Half-Life (t1/2) of ABBV-324
t1/2 of ABBV-324.
Measured: Up to Approximately 4 Years
Antidrug Antibody (ADA)
Incidence and concentration of anti-drug antibodies.
Measured: Up to Approximately 4 Years
Neutralizing Antidrug Antibody (nADA)
Incidence and concentration of neutralizing anti-drug antibodies.
Measured: Up to Approximately 4 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2025
- Study start14 Apr 2025
- Primary completionSep 2030 (estimated)
- Study completionSep 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatocellular CancerStudies of the same condition, open and under way.
- More trials run by AbbVieThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 232 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AbbVie
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- ABBVIE INC., Study director, AbbVie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06858813
- Sponsor's protocol ID
- M25-292
- Other IDs
- 2024-518012-39, 2024-518012-39-00
- Status last verified
- Sep 2026
- First submitted
- 28 Feb 2025
- Last updated
- 22 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 First-in-Human Study Evaluating Safety, Pharmacokinetics and Efficacy of ABBV 324 in Adults With Hepatocellular Cancer or Squamous Cell Non-Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT06858813
- Acronym / sponsor ID
- M25-292
- Keywords
- Hepatocellular Cancer, Squamous-Cell Non-Small Cell Lung Cancer, LUSC, HCC, ABBV-324, Lenvatinib
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 232 participants (estimated)
- Lead sponsor
- AbbVieIndustry (pharma, biotech, devices)
- Study start
- 14 Apr 2025 (actual)
- Primary completion
- Sep 2030 (estimated)
- Study completion
- Sep 2030 (estimated)
- First posted
- 5 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Part 1 Dose Escalation: ABBV-324 | Experimental | Drug: ABBV-324Participants will receive escalating doses of ABBV-324 as part of the approximately 6.5 year study duration. |
| Part 2 Dose Optimization Arm 1: ABBV-324 Dose 1 | Experimental | Drug: ABBV-324Participants will receive ABBV-324 dose 1 as part of the approximately 6.5 year study duration. |
| Part 2 Dose Optimization Arm 1: ABBV-324 Dose 2 | Experimental | Drug: ABBV-324Participants will receive ABBV-324 dose 2 as part of the approximately 6.5 year study duration. |
| Part 2 Dose Optimization Arm 1: ABBV-324 Dose 3 | Experimental | Drug: ABBV-324Participants will receive ABBV-324 dose 3 as part of the approximately 6.5 year study duration. |
| Part 2 Comparator Arm 4: Lenvatinib | Active comparator | Drug: LenvatinibParticipants will receive lenvatinib as part of the approximately 6.5 year study duration. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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.
Key exclusion criteria (8 listed)
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LenvatinibOral Capsule | Drug | Part 2 Comparator Arm 4: Lenvatinib |
| ABBV-324Intravenous (IV) Infusion | Drug | Part 1 Dose Escalation: ABBV-324, Part 2 Dose Optimization Arm 1: ABBV-324 Dose 1, Part 2 Dose Optimization Arm 1: ABBV-324 Dose 2, Part 2 Dose Optimization Arm 1: ABBV-324 Dose 3 |
Primary outcome
Number of Participants with Adverse Events (AE)s
Time frame: Up 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 Signs
Time frame: Up to Approximately 4 Years
Number of Participants with Change in Vital Signs will be assessed.
Number of Participants with Change in Electrocardiogram (ECG)
Time frame: Up to Approximately 4 Years
Number of Participants with Change in ECG will be assessed.
Number of Participants with Change in Clinical Laboratory Tests
Time frame: Up to Approximately 4 Years
Number of participants with change in clinical laboratory tests will be assessed.
Objective Response Rate (ORR)
Time frame: 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.
6 secondary outcomes
Area Under the Serum Concentration Versus Time Curve (AUC) of ABBV-324
Time frame: Up to Approximately 4 Years
Maximum Observed Serum Concentration (Cmax) of ABBV-324
Time frame: Up to Approximately 4 Years
Time to Maximum Observed Serum Concentration (Tmax) of ABBV-324
Time frame: Up to Approximately 4 Years
Terminal Elimination Half-Life (t1/2) of ABBV-324
Time frame: Up to Approximately 4 Years
Antidrug Antibody (ADA)
Time frame: Up to Approximately 4 Years
Neutralizing Antidrug Antibody (nADA)
Time frame: Up to Approximately 4 Years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2026.
- Individual participant dataSharing planned: No
Related trials for Hepatocellular Cancer
RecruitingObservational study
Real-world Evaluation of the HistoSonics Edison System for Treatment of Liver Tumors Across Multidisciplinary Users (BOOMBOX: Master Study)
Liver Neoplasms, Primary Liver Cancer
Recruiting
The Vanguard Study: Testing a New Way to Screen for Cancer
Bladder Carcinoma, Breast Carcinoma
Active, not recruitingPhase 1
Prospective Exploratory Study of FAPi PET/CT With Histopathology Validation in Patients With Various Cancers
Bladder Carcinoma, Cervical Carcinoma
RecruitingObservational study
A Study to Evaluate Patient-Reported Satisfaction, Effectiveness, and Safety of Atezolizumab in Participants Treated in Routine Clinical Practice
Lung Cancer, Hepatocellular Carcinoma
Recruiting
CREO - Microwave Ablation Feasibility Study
Pancreatic Cancer, Liver Cancer (Locally Advanced or Metastatic)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
ABBVIE INC. study director
AbbVie
22 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Lenvatinib and ABBV-324 in people with Hepatocellular Cancer and Squamous-Cell Non-Small Cell Lung Cancer, run by AbbVie at 22 sites in 7 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 sites in United States, Israel, Japan, China, Spain and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact ABBVIE CALL CENTER (844-663-3742, abbvieclinicaltrials@abbvie.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with Adverse Events (AE)s (time frame: Up to Approximately 4 Years). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2026.