What side effects are associated with this type of intervention?

Common treatments for B-cell cancers, such as monoclonal antibodies (e.g., rituximab), BTK inhibitors (e.g., ibrutinib), and chemotherapy agents (e.g., bendamustine), often have side effects including infusion reactions, infections, cytopenias, diarrhea, bleeding, atrial fibrillation, myelosuppression, nausea, vomiting, and increased risk of infections. The investigational drug ABBV-525, currently being studied, may share similar side effects, but its specific profile is still under investigation.

What prior FDA approvals exist?

The FDA has approved several drugs for the treatment of B-cell cancers, including monoclonal antibodies like rituximab, ofatumumab, and obinutuzumab, which target the CD20 antigen on B-cells. Kinase inhibitors such as ibrutinib, acalabrutinib, and zanubrutinib, which inhibit Bruton's tyrosine kinase (BTK), have also been approved. These treatments have shown efficacy in various B-cell malignancies, including chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL), with varying safety profiles. The investigational drug ABBV-525 is being studied for its potential to provide a new therapeutic option in this category.

What other types of research exist?

Promising alternatives to ABBV-525 for B-cell malignancies include: 1) Ibrutinib, which has shown efficacy in various B-cell cancers such as chronic lymphocytic leukemia (CLL) and mantle cell lymphoma (MCL). 2) Acalabrutinib, noted for its reduced off-target effects and greater BTK occupancy compared to ibrutinib. 3) Venetoclax, which has demonstrated high response rates in combination therapies for CLL. 4) Obinutuzumab, often used in combination with other agents like venetoclax or ibrutinib for enhanced efficacy. These alternatives have been validated in multiple clinical trials and offer promising treatment options for B-cell malignancies.

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Monoclonal Antibodies

ABBV-525 for B-Cell Cancers

Phase 1

Recruiting

Research Sponsored by AbbVie

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to approximately 64 months

Awards & highlights

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

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).

What are the potential side effects?

Potential side effects aren't specified but may include typical reactions related to oral cancer medications such as nausea, fatigue, liver issues or blood count changes. Regular hospital visits will monitor for these and other adverse events.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to approximately 64 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to approximately 64 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 64 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Area Under the Plasma Concentration-Time Curve (AUC) of ABBV-525

Maximum Observed Plasma Concentration (Cmax) of ABBV-525

Number of Participants With Adverse Events (AE)

+6 more

Secondary study objectives

Duration of Response (DOR)

Overall Response Rate (ORR)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Experimental Treatment

Group I: ABBV-525 Dose OptimizationExperimental Treatment1 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 ExpansionExperimental Treatment1 Intervention

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

Group III: ABBV-525 Dose EscalationExperimental Treatment1 Intervention

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

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Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for B-Cell Cancers, such as chronic lymphocytic leukemia (CLL), include targeted therapies like Bruton tyrosine kinase (BTK) inhibitors (e.g., ibrutinib, acalabrutinib) and BCL-2 inhibitors (e.g., venetoclax). BTK inhibitors block the BTK enzyme, which is crucial for B-cell receptor signaling, thereby inhibiting cancer cell proliferation and survival. BCL-2 inhibitors induce apoptosis in cancer cells by targeting the BCL-2 protein, which prevents programmed cell death. These mechanisms are vital for B-Cell Cancer patients as they offer more precise and effective treatment options with potentially fewer side effects compared to traditional chemotherapy. Investigational drugs like ABBV-525 aim to further refine these targeted approaches, potentially improving outcomes and quality of life for patients.

Agony of choice-selecting chronic lymphocytic leukemia treatment in 2022.