ABBV-525 for B-Cell Cancers
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.12345Why 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.12456
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Dose Escalation
Participants receive escalating oral doses of ABBV-525 to determine doses for optimization
Dose Optimization
Participants receive one of two oral doses of ABBV-525 until the recommended phase 2 dose is determined
Dose Expansion
Participants receive the recommended phase 2 dose of ABBV-525
Follow-up
Participants are monitored for safety and effectiveness after treatment
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?
3
Treatment groups
Experimental Treatment
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.
Participants will receive the RP2D dose of ABBV-525, as part of an approximately 64 month study period.
Participants will receive escalating doses of ABBV-525 until doses for optimization are determined, as part of an approximately 64 month study period.
Find a Clinic Near You
Who Is Running the Clinical Trial?
AbbVie
Lead Sponsor
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-SmallA 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.
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.
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-malignanciesA 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.
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 ...
M23-324
Study to evaluate adverse events and change in disease activity in adult participants with B-cell malignancies receiving oral ABBV-525 tablets.
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