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Study to Evaluate Adverse Events and Change in Disease Activity in Adult Participants With B-Cell Malignancies Receiving Oral ABBV-525 Tablets
NCT05618028 · View on ClinicalTrials.gov ↗
Study Summary
B-cell malignancies are a group of cancers of B lymphocytes, a type of white blood cell responsible for fighting infections. The purpose of this study is to assess safety, tolerability, pharmacokinetics and preliminary efficacy of ABBV-525 as a monotherapy. ABBV-525 is an investigational drug being developed for the treatment of B-Cell Malignancies. Study doctors put the participants in groups called treatment arms. Participants will receive ABBV-525 at different doses. Approximately 150 adult participants will be enrolled in the study across sites worldwide. In part 1 (dose escalation), participants will receive escalating oral doses of ABBV-525. In part 2 (dose optimization), participants will receive one of two oral doses of ABBV-525, until the recommended phase 2 dose (RP2D) is determined. In part 3 (dose expansion), participants will receive the RP2D oral dose of ABBV-525. The estimated duration of the study is up to 64 months. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic and may require frequent medical assessments, blood tests, and scans.
Conditions Studied
Interventions
- DRUG ABBV-525
Study Locations (20)
Indiana
- Fort Wayne Medical Oncology and Hematology, Inc /ID# 250113 — Fort Wayne
- Indiana University Melvin and Bren Simon Comprehensive Cancer Center /ID# 259872 — Indianapolis
New South Wales
- Liverpool Hospital /ID# 260191 — Liverpool
- Orange Health Service /ID# 260473 — Orange
Victoria
- Monash Health - Monash Medical Centre /ID# 246366 — Clayton
- The Alfred Hospital /ID# 248592 — Melbourne
California
- University of California Los Angeles Medical Center /ID# 246357 — Los Angeles
Connecticut
- Yale University School of Medicine /ID# 259081 — New Haven
Florida
- Mount Sinai Medical Center-Miami Beach /ID# 248251 — Miami Beach
Louisiana
- Tulane Cancer Center Clinic /ID# 249586 — New Orleans
Michigan
- START Midwest /ID# 252359 — Grand Rapids
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 150 participants |
| Start Date | 2023-04-04 |
| Est. Completion | 2029-07 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05618028
The ClinicalTrials.gov registry entry for NCT05618028 describes a study currently listed as recruiting. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 150 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is AbbVie, which has 603 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 4 conditions, with Chronic Lymphocytic Leukemia appearing as the primary indexed condition, and to 1 intervention — of which ABBV-525 is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05618028 reports 20 study locations spanning 17 distinct geographic areas — top geographies include Indiana, New South Wales, Victoria. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT05618028 about?
NCT05618028 is a clinical study titled "Study to Evaluate Adverse Events and Change in Disease Activity in Adult Participants With B-Cell Malignancies Receiving Oral ABBV-525 Tablets". B-cell malignancies are a group of cancers of B lymphocytes, a type of white blood cell responsible for fighting infections. The purpose of this study is to assess safety, tolerability, pharmacokinetics and preliminary efficacy of ABBV-525 as a monotherapy. ABBV-525 is an investigational drug being...
What is the current status of trial NCT05618028?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 150 participants. The study started on 2023-04-04. Estimated completion is 2029-07.
What conditions does trial NCT05618028 study?
This clinical trial studies the following conditions: Chronic Lymphocytic Leukemia, Non-Hodgkin's Lymphoma, Diffuse Large B-Cell Lymphoma, B Cell Malignancies. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05618028?
The interventions under investigation include: ABBV-525 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05618028?
This trial is sponsored by AbbVie, which has 603 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT05618028 being conducted?
This trial has 20 study locations across California, Connecticut, Florida, Indiana, Louisiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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