ABBV-324 for Liver and Lung Cancers

Recruiting at 6 trial locations

Overseen By ABBVIE CALL CENTER

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: AbbVie

Must not be taking: Steroids

Disqualifiers: Brain metastases, ILD, pulmonary disorders, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

232 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Research Team

ABBVIE INC.

Principal Investigator

AbbVie

Eligibility Criteria

Adults with advanced liver cancer (HCC) or squamous-cell non-small cell lung cancer (LUSC) that can't be removed by surgery. Participants must have tried at least one systemic treatment before, have specific lab values within protocol criteria, and a performance status showing they're mostly active. Those with certain heart conditions or mixed liver cancers are excluded.

Inclusion Criteria

My lab results meet the study's requirements.

I have had at least one treatment for liver cancer that did not work.

My cancer can be measured using specific criteria.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation

Participants receive escalating doses of ABBV-324 to determine the tolerable and efficacious dose

Part of the 6.5-year study duration

Regular visits at approved institutions

Dose Optimization

Participants receive optimized doses of ABBV-324 or comparator drug lenvatinib

Part of the 6.5-year study duration

Regular visits at approved institutions

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to approximately 4 years

Treatment Details

Interventions

• ABBV-324

Trial Overview The trial is testing ABBV-324 given intravenously to treat HCC and LUSC. It includes two stages: dose escalation to find a tolerable dose, and dose optimization comparing ABBV-324 with oral lenvatinib. The study aims to assess side effects and disease activity changes over approximately 6.5 years across various global sites.

Participant Groups

Group I: Part 2 Dose Optimization Arm 1: ABBV-324 Dose 3 Experimental Treatment 1 Intervention

Participants will receive ABBV-324 dose 3 as part of the approximately 6.5 year study duration.

Group II: Part 2 Dose Optimization Arm 1: ABBV-324 Dose 2 Experimental Treatment 1 Intervention

Participants will receive ABBV-324 dose 2 as part of the approximately 6.5 year study duration.

Group III: Part 2 Dose Optimization Arm 1: ABBV-324 Dose 1 Experimental Treatment 1 Intervention

Participants will receive ABBV-324 dose 1 as part of the approximately 6.5 year study duration.

Group IV: Part 1 Dose Escalation: ABBV-324 Experimental Treatment 1 Intervention

Participants will receive escalating doses of ABBV-324 as part of the approximately 6.5 year study duration.

Group V: Part 2 Comparator Arm 4: Lenvatinib Active Control 1 Intervention

Participants will receive lenvatinib as part of the approximately 6.5 year study duration.

Who Is Running the Clinical Trial?

AbbVie

Lead Sponsor

Trials

1,079

Recruited

535,000+

Founded

2013

Headquarters

North Chicago, USA

Known For

Immunology treatments

Top Products

Humira (adalimumab), Skyrizi (risankizumab), Rinvoq (upadacitinib)

Dr. Roopal Thakkar

AbbVie

Chief Medical Officer since 2023

MD from Wayne State University School of Medicine

Robert A. Michael

AbbVie

Chief Executive Officer

Bachelor's degree in Finance from the University of Illinois