ABBV-324 for Liver and Lung Cancers

Recruiting at 21 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests ABBV-324, a new drug for treating liver cancer (HCC) and squamous-cell non-small cell lung cancer (LUSC). Researchers aim to assess the drug's safety and its impact on cancer progression. Participants will receive varying doses of ABBV-324 or a comparison drug, lenvatinib, while doctors closely monitor side effects and the cancer's response. This trial suits individuals with advanced or difficult-to-treat liver or lung cancer who have already tried at least one other treatment. As a Phase 1 trial, participants will be among the first to receive this new treatment, aiding researchers in understanding its effects in people.

Will I have to stop taking my current medications?

You will need to stop taking any anticancer therapies, including chemotherapy, radiation, immunotherapy, or biologic treatments, at least 14 days before starting the trial drug ABBV-324. However, palliative radiation for certain conditions is allowed without a waiting period.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that the safety of ABBV-324 in humans remains under exploration. This drug is in the early testing stages, so detailed safety information is limited. The main goal at this stage is to assess tolerance and determine the appropriate dose.

Since ABBV-324 is undergoing its first human tests, unexpected side effects may occur. However, the study closely monitors participants for any adverse events. This monitoring is crucial to ensure the drug's safety before wider use.

Participants in this study receive different doses of ABBV-324 to help researchers determine safe and effective amounts. The process is careful and gradual to ensure participant safety. If ABBV-324 is well-tolerated, participants can handle the treatment without serious problems.

Understanding the safety of ABBV-324 is a major focus of the research, as this is its first human trial. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for liver and lung cancers?

Researchers are excited about ABBV-324 for liver and lung cancers because it offers a fresh approach compared to existing treatments like chemotherapy and targeted therapies such as sorafenib and lenvatinib. Unlike these standard treatments, ABBV-324 is designed to target specific pathways involved in cancer cell growth, potentially offering a more precise mechanism of action. This targeted approach could lead to fewer side effects and improved effectiveness. Additionally, ABBV-324 is being tested at multiple dose levels to optimize its impact, which might enhance its therapeutic potential against these challenging cancers.

What evidence suggests that this trial's treatments could be effective for liver and lung cancers?

Research has shown that ABBV-324 is being tested as a potential treatment for liver cancer (HCC) and a type of lung cancer (LUSC). In this trial, participants receive varying doses of ABBV-324 to identify the optimal dose that is both safe and effective. Early results suggest that ABBV-324 targets specific parts of cancer cells, potentially slowing or stopping their growth. Although human studies have provided limited information so far, early research focuses on understanding the drug's safety and its effects on cancer. As more research is conducted, clearer evidence about ABBV-324's effectiveness against these cancers is anticipated. ^{1 2 3 6 7}

Who Is on the Research Team?

ABBVIE INC.

Principal Investigator

AbbVie

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06858813

NCT06858813 | A Study to Assess Adverse Events and ... 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 ...

2. mskcc.org mskcc.org/cancer-care/clinical-trials/25-209

A Phase 1 Study of ABBV-324 in People With ... Full Title A Phase 1 First-in-Human Study Evaluating Safety, Pharmacokinetics, and Efficacy of ABBV-324 in Adults with Hepatocellular Cancer ...

3. abbvieclinicaltrials.com abbvieclinicaltrials.com/study/?id=M25-292

M25-292 A study to assess adverse events and change in disease activity of intravenously (IV) infused ABBV-324 in adult participants with hepatocellular cancer (HCC)

4. clinicaltrials.ucbraid.org clinicaltrials.ucbraid.org/hepatocellular-cancer

Hepatocellular Cancer clinical trials at University of California ... The purpose of this study is to evaluate the safety and effectiveness of triplet therapy of nivolumab, relatlimab and bevacizumab versus ...

5. tipranks.com tipranks.com/news/company-announcements/abbvies-promising-phase-1-study-on-abbv-324-for-cancer-treatment

AbbVie's Promising Phase 1 Study on ABBV-324 ... ABBV-324 is being developed to treat HCC and LUSC, with the goal of determining its safety and efficacy.

6. theglobeandmail.com theglobeandmail.com/investing/markets/stocks/ABBV/pressreleases/34506107/abbvies-abbv-324-study-a-new-hope-for-cancer-treatment/

AbbVie's ABBV-324 Study: A New Hope for Cancer ... ' The study aims to assess adverse events and changes in disease activity when ABBV-324 is administered to adults with hepatocellular cancer ( ...

7. jeffersonhealth.org jeffersonhealth.org/clinical-specialties/cancer/clinical-trials/45713

Clinical Trial 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 ...