Study to Evaluate Adverse Events and Change in Disease Activity in Adult Participants With B-Cell Malignancies Receiving Oral ABBV-525 Tablets
Public ClinicalTrials.gov record NCT05618028. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A First-in-Human Study of ABBV-525 (MALT1 Inhibitor) in B-Cell Malignancies
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT05618028
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 1
- Enrollment
- 78 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Apr 3, 2023
- Primary completion
- Jun 30, 2029
- Completion
- Jun 30, 2029
- Last update posted
- May 3, 2026
2023 – 2029
United States locations
- U.S. sites
- 13
- U.S. states
- 12
- U.S. cities
- 13
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of California Los Angeles Medical Center /ID# 246357 | Los Angeles | California | 90095 | — |
| Yale University School of Medicine /ID# 259081 | New Haven | Connecticut | 06510 | — |
| Mount Sinai Medical Center-Miami Beach /ID# 248251 | Miami Beach | Florida | 33140-2948 | — |
| Fort Wayne Medical Oncology and Hematology, Inc /ID# 250113 | Fort Wayne | Indiana | 46804 | — |
| Indiana University Melvin and Bren Simon Comprehensive Cancer Center /ID# 259872 | Indianapolis | Indiana | 46202-5116 | — |
| Tulane Cancer Center Clinic /ID# 249586 | New Orleans | Louisiana | 70112 | — |
| START Midwest /ID# 252359 | Grand Rapids | Michigan | 49546 | — |
| Memorial Sloan Kettering Cancer Center-Koch Center /ID# 245459 | New York | New York | 10065-6007 | — |
| Atrium Health Levine Cancer Institute /ID# 246363 | Charlotte | North Carolina | 28204 | — |
| University Of Cincinnati Medical Center /ID# 262288 | Cincinnati | Ohio | 45219 | — |
| University of Texas MD Anderson Cancer Center /ID# 245463 | Houston | Texas | 77030 | — |
| University of Utah Health Hospital /ID# 259924 | Salt Lake City | Utah | 84132 | — |
| Northwest Medical Specialties - Tacoma /ID# 260376 | Tacoma | Washington | 98405 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 26 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05618028, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted May 3, 2026 · Synced Sep 10, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT05618028 live on ClinicalTrials.gov.