ABBV-525 for B-Cell Cancers

Recruiting at 50 trial locations

Overseen By ABBVIE CALL CENTER

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: AbbVie

Disqualifiers: Active CNS disease, Bleeding disorders, Stroke, others

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

Compensation: Varies

Number of Visits: Unknown

150 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine the best dose of an experimental drug called ABBV-525 for individuals with B-Cell cancers. B-Cell cancers affect white blood cells that help fight infections. The trial will test different doses to assess the drug's safety and effectiveness. Those who have tried at least two other cancer treatments and still require treatment might be suitable for this study. Participants should be prepared for regular hospital visits and medical tests throughout the trial. As a Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new drug.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the study doctors to understand how your current treatments might interact with the trial.

Is there any evidence suggesting that ABBV-525 is likely to be safe for humans?

Research shows that ABBV-525 remains in the early stages of human testing. As a new treatment for B-cell cancers, assessing its safety is crucial. Currently, researchers are testing ABBV-525 to determine the highest dose people can tolerate with minimal side effects.

Since this is an early trial, researchers are still collecting safety information. These trials typically involve small groups to identify any side effects. Researchers aim to understand how well participants can tolerate ABBV-525, including monitoring for any unexpected medical issues during the study.

While ABBV-525 is under study, participants must attend regular medical check-ups. This allows doctors to monitor safety and manage any side effects as they occur. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about ABBV-525 because it represents a novel approach to treating B-cell cancers. Unlike standard treatments like chemotherapy and immunotherapy, ABBV-525 is designed to precisely target specific cancer cell pathways. This targeted action could potentially reduce side effects and improve outcomes. Additionally, ABBV-525 is administered in escalating doses to find the optimal therapeutic level, which could enhance its effectiveness compared to current treatments.

What evidence suggests that ABBV-525 could be an effective treatment for B-Cell Malignancies?

Research has shown that ABBV-525 blocks a protein called MALT1, which aids the growth of B-cell cancers. Early studies indicate that ABBV-525 can slow cancer cells in individuals whose B-cell cancers have recurred or resisted other treatments. This trial will explore various dosing strategies for ABBV-525, including dose escalation, dose optimization, and dose expansion, to assess its effectiveness and safety. Initial findings suggest that this drug can work independently, without needing combination with other drugs. However, further research is necessary to fully understand its efficacy and safety. ^{1 2 4 5 6}

Who Is on the Research Team?

ABBVIE INC.

Principal Investigator

AbbVie

Are You a Good Fit for This Trial?

Adults with certain advanced B-cell malignancies, who are in good physical condition (ECOG PS of 0 or 1), expected to live at least 12 weeks, and have recovered from COVID-19 can join. They must not have active brain cancer, bleeding disorders, recent strokes, uncontrolled infections including hepatitis B/C or HIV, nor be currently sick with COVID-19.

Inclusion Criteria

Participant has a life expectancy >= 12 weeks

My blood and liver tests meet the study's requirements.

I am fully active or restricted in physically strenuous activity but can do light work.

Exclusion Criteria

Known history of human immunodeficiency virus (HIV)

Active hepatitis B or C infection

I have not had a stroke or brain bleed in the last year.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation

Participants receive escalating oral doses of ABBV-525 to determine doses for optimization

Up to 64 months

Regular visits at a hospital or clinic

Dose Optimization

Participants receive one of two oral doses of ABBV-525 until the recommended phase 2 dose is determined

Up to 64 months

Regular visits at a hospital or clinic

Dose Expansion

Participants receive the recommended phase 2 dose of ABBV-525

Up to 64 months

Regular visits at a hospital or clinic

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• ABBV-525

Trial Overview The trial is testing ABBV-525 tablets for treating various types of B-cell cancers. It has three parts: increasing doses to find the safest amount (dose escalation), finding the best dose among two options (dose optimization), and then giving that best dose to more people (dose expansion).

How Is the Trial Designed?

Group I: ABBV-525 Dose Optimization Experimental Treatment 1 Intervention

Participants will receive one of two doses of ABBV-525 until the recommended phase 2 dose (RP2D) is determined, as part of an approximately 64 month study period.

Group II: ABBV-525 Dose Expansion Experimental Treatment 1 Intervention

Participants will receive the RP2D dose of ABBV-525, as part of an approximately 64 month study period.

Group III: ABBV-525 Dose Escalation Experimental Treatment 1 Intervention

Participants will receive escalating doses of ABBV-525 until doses for optimization are determined, as part of an approximately 64 month study period.

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. ashpublications.org ashpublications.org/blood/article/142/Supplement%201/3101/503815/A-First-in-Human-Phase-1-Study-of-ABBV-525-a-Small

A First-in-Human Phase 1 Study of ABBV-525, a Small ... This phase 1 study evaluates the clinical candidate MALT1 inhibitor ABBV-525 as monotherapy in pts with relapsed or refractory (R/R) B-cell NHL.

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0006497123097033

A First-in-Human Phase 1 Study of ABBV-525, a Small- ... This phase 1 study evaluates the clinical candidate MALT1 inhibitor ABBV-525 as monotherapy in pts with relapsed or refractory (R/R) B-cell NHL.

3. clinicaltrials.gov clinicaltrials.gov/study/NCT05618028

NCT05618028 | Study to Evaluate Adverse Events and ... The purpose of this study is to assess safety, tolerability, pharmacokinetics and preliminary efficacy of ABBV-525 as a monotherapy.

4. yalemedicine.org yalemedicine.org/clinical-trials/m23-324-a-first-in-human-study-of-abbv-525-malt1-inhibitor-in-b-cell-malignancies

A First-in-Human Study of ABBV-525 (MALT1 Inhibitor) in B ... The purpose of this study is to assess safety, tolerability, pharmacokinetics and preliminary efficacy of ABBV-525 as a monotherapy.

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11217731/

Inhibition of MALT1 and BCL2 Induces Synergistic ... ABBV-MALT1 primes cancer cells for BCL2 inhibition. Single-agent kinase inhibitors have historically shown limited activity in patients with DLBCL, leading us ...

6. abbvieclinicaltrials.com abbvieclinicaltrials.com/study/?id=M23-324

M23-324 Study to evaluate adverse events and change in disease activity in adult participants with B-cell malignancies receiving oral ABBV-525 tablets.