NCT05618028Active, not recruitingPhase 1
Study to Evaluate Adverse Events and Change in Disease Activity in Adult Participants With B-Cell Malignancies Receiving Oral ABBV-525 Tablets
A First-in-Human Study of ABBV-525 (MALT1 Inhibitor) in B-Cell Malignancies
Source: ClinicalTrials.gov · Last updated 4 May 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 78 (actual)
- First submitted
- 14 Nov 2022
- Start date
- Apr 2023
- Primary completion date
- Jul 2029
- Lead sponsor
- AbbVie
- NCT number
- NCT05618028
- EU CT number
- 2022-503136-13-00
- EudraCT number
- 2022-503136-13
What you commit to
- Study type: Interventional · Phase 1
- Participants enrolled: 78
- From Apr 2023 to the primary completion date, Jul 2029
- 39 sites in 10 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Known history of stroke or intracranial hemorrhage within 12 months prior to first dose of study treatment.
Other illness
- Known active CNS disease, or primary CNS lymphoma.
- Known bleeding disorders.
- Uncontrolled active systemic infection, or active cytomegalovirus infection.
- Active and/or chronic hepatitis B or C infection and/or the criteria listed in the protocol.
- Known history of human immunodeficiency virus (HIV).
- Known active COVID-19 infection. Participant must not have signs/symptoms associated with COVID-19 infection or known exposure to a confirmed case of COVID-19 infection during screening. If participant has signs/symptoms suggestive of COVID-19 infection, the participant must have a negative molecular (e.g., polymerase chain reaction) test or 3 negative antigen test results at least 24 hours apart.
Who the study is looking for
- Dose Escalation (Part 1) Only: Participants with a documented diagnosis of one of the following third line or later of treatment (3L)+ mature B-cell malignancies, from the World Health Organization (WHO)-defined histologies as defined in the protocol.
- Dose Optimization (Part 2) Only: Participants with documented diagnosis of chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL) with histology based on WHO criteria, with measurable disease requiring treatment as defined by the International Workshop on Chronic Lymphocytic Leukemia (iwCLL).
- Dose Expansion (Part 3) Only: Participants with documented diagnosis of one of the 3L+ mature B-cell malignancies based on WHO criteria listed in the protocol, with measurable disease requiring treatment.
- Participant has an Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0, 1, or 2.
- Participant has a life expectancy \>= 12 weeks.
- Adequate hematological and hepatic function as defined in the protocol.
- Must have archival or freshly collected tumor tissue for correlative studies before study enrollment.
- Participants with prior central nervous system (CNS) disease that has been effectively treated may be eligible.
- Participants with resolved coronavirus disease 2019 (COVID-19) infection are eligible.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (39)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Bankstown-Lidcombe Hospital /ID# 260191 Coordinator of this site? Confirm its status | Bankstown | Australia | Unknown status |
| Monash Health - Monash Medical Centre /ID# 246366 Coordinator of this site? Confirm its status | Clayton | Australia | Unknown status |
| The Alfred Hospital /ID# 248592 Coordinator of this site? Confirm its status | Melbourne | Australia | Unknown status |
| Orange Health Service /ID# 260473 Coordinator of this site? Confirm its status | Orange | Australia | Unknown status |
| UZ Gent /ID# 246462 Coordinator of this site? Confirm its status | Ghent | Belgium | Unknown status |
| Universitair Ziekenhuis Leuven /ID# 246461 Coordinator of this site? Confirm its status | Leuven | Belgium | Unknown status |
| Charite Universitaetsmedizin Berlin Campus Virchow-Klinikum /ID# 252062 Coordinator of this site? Confirm its status | Berlin | Germany | Unknown status |
| Hospital Universitario Vall de Hebron /ID# 245475 Coordinator of this site? Confirm its status | Barcelona | Spain | Unknown status |
| Hospital Clinic de Barcelona /ID# 246543 Coordinator of this site? Confirm its status | Barcelona | Spain | Unknown status |
| Institut Català d'Oncologia (ICO) - L'Hospitalet /ID# 246537 Coordinator of this site? Confirm its status | L'Hospitalet de Llobregat | Spain | Unknown status |
| Hospital Universitario 12 de Octubre /ID# 246538 Coordinator of this site? Confirm its status | Madrid | Spain | Unknown status |
| Hospital Universitario Ramon y Cajal /ID# 246540 Coordinator of this site? Confirm its status | Madrid | Spain | Unknown status |
| CHRU Lille - Hopital Claude Huriez /ID# 252054 Coordinator of this site? Confirm its status | Lille | France | Unknown status |
| IUCT Oncopole /ID# 259409 Coordinator of this site? Confirm its status | Toulouse | France | Unknown status |
| Leeds Teaching Hospitals NHS Trust /ID# 245470 Coordinator of this site? Confirm its status | Leeds | United Kingdom | Unknown status |
| The Royal Marsden NHS Foundation Trust /ID# 250324 Coordinator of this site? Confirm its status | London | United Kingdom | Unknown status |
| The Christie Hospital /ID# 250325 Coordinator of this site? Confirm its status | Manchester | United Kingdom | Unknown status |
| Shamir Medical Center /ID# 257711 Coordinator of this site? Confirm its status | Beer Ya'akov | Israel | Unknown status |
| Hadassah Medical Center-Hebrew University /ID# 251441 Coordinator of this site? Confirm its status | Jerusalem | Israel | Unknown status |
| Rabin Medical Center. /ID# 257665 Coordinator of this site? Confirm its status | Petah Tikva | Israel | Unknown status |
| The Chaim Sheba Medical Center /ID# 251442 Coordinator of this site? Confirm its status | Ramat Gan | Israel | Unknown status |
| Samsung Medical Center /ID# 266415 Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Asan Medical Center /ID# 266341 Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Seoul National University Hospital /ID# 266340 Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| China Medical University Hospital /ID# 266414 Coordinator of this site? Confirm its status | Taichung | Taiwan | Unknown status |
| National Taiwan University Hospital /ID# 266343 Coordinator of this site? Confirm its status | Taipei | Taiwan | Unknown status |
| Atrium Health Levine Cancer Institute /ID# 246363 Coordinator of this site? Confirm its status | Charlotte | United States | Unknown status |
| University Of Cincinnati Medical Center /ID# 262288 Coordinator of this site? Confirm its status | Cincinnati | United States | Unknown status |
| Fort Wayne Medical Oncology and Hematology, Inc /ID# 250113 Coordinator of this site? Confirm its status | Fort Wayne | United States | Unknown status |
| START Midwest /ID# 252359 Coordinator of this site? Confirm its status | Grand Rapids | United States | Unknown status |
| University of Texas MD Anderson Cancer Center /ID# 245463 Coordinator of this site? Confirm its status | Houston | United States | Unknown status |
| Indiana University Melvin and Bren Simon Comprehensive Cancer Center /ID# 259872 Coordinator of this site? Confirm its status | Indianapolis | United States | Unknown status |
| University of California Los Angeles Medical Center /ID# 246357 Coordinator of this site? Confirm its status | Los Angeles | United States | Unknown status |
| Mount Sinai Medical Center-Miami Beach /ID# 248251 Coordinator of this site? Confirm its status | Miami Beach | United States | Unknown status |
| Yale University School of Medicine /ID# 259081 Coordinator of this site? Confirm its status | New Haven | United States | Unknown status |
| Tulane Cancer Center Clinic /ID# 249586 Coordinator of this site? Confirm its status | New Orleans | United States | Unknown status |
| Memorial Sloan Kettering Cancer Center-Koch Center /ID# 245459 Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| University of Utah Health Hospital /ID# 259924 Coordinator of this site? Confirm its status | Salt Lake City | United States | Unknown status |
| Northwest Medical Specialties - Tacoma /ID# 260376 Coordinator of this site? Confirm its status | Tacoma | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.