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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

Full criteria on ClinicalTrials.gov

Sites (39)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Bankstown-Lidcombe Hospital /ID# 260191
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BankstownAustraliaUnknown status
Monash Health - Monash Medical Centre /ID# 246366
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ClaytonAustraliaUnknown status
The Alfred Hospital /ID# 248592
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MelbourneAustraliaUnknown status
Orange Health Service /ID# 260473
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OrangeAustraliaUnknown status
UZ Gent /ID# 246462
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GhentBelgiumUnknown status
Universitair Ziekenhuis Leuven /ID# 246461
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LeuvenBelgiumUnknown status
Charite Universitaetsmedizin Berlin Campus Virchow-Klinikum /ID# 252062
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BerlinGermanyUnknown status
Hospital Universitario Vall de Hebron /ID# 245475
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BarcelonaSpainUnknown status
Hospital Clinic de Barcelona /ID# 246543
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BarcelonaSpainUnknown status
Institut Català d'Oncologia (ICO) - L'Hospitalet /ID# 246537
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L'Hospitalet de LlobregatSpainUnknown status
Hospital Universitario 12 de Octubre /ID# 246538
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MadridSpainUnknown status
Hospital Universitario Ramon y Cajal /ID# 246540
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MadridSpainUnknown status
CHRU Lille - Hopital Claude Huriez /ID# 252054
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LilleFranceUnknown status
IUCT Oncopole /ID# 259409
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ToulouseFranceUnknown status
Leeds Teaching Hospitals NHS Trust /ID# 245470
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LeedsUnited KingdomUnknown status
The Royal Marsden NHS Foundation Trust /ID# 250324
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LondonUnited KingdomUnknown status
The Christie Hospital /ID# 250325
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ManchesterUnited KingdomUnknown status
Shamir Medical Center /ID# 257711
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Beer Ya'akovIsraelUnknown status
Hadassah Medical Center-Hebrew University /ID# 251441
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JerusalemIsraelUnknown status
Rabin Medical Center. /ID# 257665
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Petah TikvaIsraelUnknown status
The Chaim Sheba Medical Center /ID# 251442
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Ramat GanIsraelUnknown status
Samsung Medical Center /ID# 266415
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SeoulSouth KoreaUnknown status
Asan Medical Center /ID# 266341
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SeoulSouth KoreaUnknown status
Seoul National University Hospital /ID# 266340
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SeoulSouth KoreaUnknown status
China Medical University Hospital /ID# 266414
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TaichungTaiwanUnknown status
National Taiwan University Hospital /ID# 266343
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TaipeiTaiwanUnknown status
Atrium Health Levine Cancer Institute /ID# 246363
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CharlotteUnited StatesUnknown status
University Of Cincinnati Medical Center /ID# 262288
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CincinnatiUnited StatesUnknown status
Fort Wayne Medical Oncology and Hematology, Inc /ID# 250113
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Fort WayneUnited StatesUnknown status
START Midwest /ID# 252359
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Grand RapidsUnited StatesUnknown status
University of Texas MD Anderson Cancer Center /ID# 245463
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HoustonUnited StatesUnknown status
Indiana University Melvin and Bren Simon Comprehensive Cancer Center /ID# 259872
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IndianapolisUnited StatesUnknown status
University of California Los Angeles Medical Center /ID# 246357
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Los AngelesUnited StatesUnknown status
Mount Sinai Medical Center-Miami Beach /ID# 248251
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Miami BeachUnited StatesUnknown status
Yale University School of Medicine /ID# 259081
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New HavenUnited StatesUnknown status
Tulane Cancer Center Clinic /ID# 249586
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New OrleansUnited StatesUnknown status
Memorial Sloan Kettering Cancer Center-Koch Center /ID# 245459
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New YorkUnited StatesUnknown status
University of Utah Health Hospital /ID# 259924
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Salt Lake CityUnited StatesUnknown status
Northwest Medical Specialties - Tacoma /ID# 260376
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TacomaUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.