ABBV-525 for B-Cell Cancers

Recruiting at 41 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

100 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial tests a new drug called ABBV-525 for treating a type of white blood cell cancer. It involves adults with this cancer and aims to find the best dose by giving the drug in different amounts. The study will last several years and requires frequent check-ups.

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.

Research Team

ABBVIE INC.

Principal Investigator

AbbVie

Eligibility Criteria

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

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

Treatment Details

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).

Participant Groups

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