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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 · AbbVie
In plain English
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Official title
A First-in-Human Study of ABBV-525 (MALT1 Inhibitor) in B-Cell Malignancies
About this study
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.
Eligibility criteria
Inclusion Criteria:
* 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.
Exclusion Criteria:
* Known active CNS disease, or primary CNS lymphoma.
* Known bleeding disorders.
* Known history of stroke or intracranial hemorrhage within 12 months prior to first dose of study treatment.
* 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.
Study design
Enrollment target: 150 participants
Allocation: randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2023-04-04
Estimated completion: 2029-07
Last updated: 2026-02-12
Interventions
Drug: ABBV-525
Primary outcomes
- • Number of Participants With Adverse Events (AE) (Up to Approximately 64 Months)
- • Number of Participants With Dose-Limiting Toxicities (DLT) (Up to Approximately 28 Days)
- • Number of Tumor Lysis Syndrome (TLS) (Up to Approximately 64 Months)
Sponsor
AbbVie · industry
Contacts & investigators
ContactABBVIE CALL CENTER · contact · abbvieclinicaltrials@abbvie.com · 844-663-3742
InvestigatorABBVIE INC. · study_director, AbbVie
All locations (39)
University of California Los Angeles Medical Center /ID# 246357Recruiting
Los Angeles, California, United States
Yale University School of Medicine /ID# 259081Recruiting
New Haven, Connecticut, United States
Mount Sinai Medical Center-Miami Beach /ID# 248251Completed
Miami Beach, Florida, United States
Fort Wayne Medical Oncology and Hematology, Inc /ID# 250113Recruiting
Fort Wayne, Indiana, United States
Indiana University Melvin and Bren Simon Comprehensive Cancer Center /ID# 259872Recruiting
Indianapolis, Indiana, United States
Tulane Cancer Center Clinic /ID# 249586Completed
New Orleans, Louisiana, United States
START Midwest /ID# 252359Recruiting
Grand Rapids, Michigan, United States
Memorial Sloan Kettering Cancer Center-Koch Center /ID# 245459Recruiting
New York, New York, United States
Atrium Health Levine Cancer Institute /ID# 246363Recruiting
Charlotte, North Carolina, United States
University Of Cincinnati Medical Center /ID# 262288Completed
Cincinnati, Ohio, United States
University of Texas MD Anderson Cancer Center /ID# 245463Recruiting
Houston, Texas, United States
University of Utah Health Hospital /ID# 259924Recruiting
Salt Lake City, Utah, United States
Northwest Medical Specialties - Tacoma /ID# 260376Recruiting
Tacoma, Washington, United States
Liverpool Hospital /ID# 260191Recruiting
Liverpool, New South Wales, Australia
Orange Health Service /ID# 260473Recruiting
Orange, New South Wales, Australia
Monash Health - Monash Medical Centre /ID# 246366Recruiting
Clayton, Victoria, Australia
The Alfred Hospital /ID# 248592Recruiting
Melbourne, Victoria, Australia
UZ Gent /ID# 246462Recruiting
Ghent, Oost-Vlaanderen, Belgium
Universitair Ziekenhuis Leuven /ID# 246461Recruiting
Leuven, Vlaams-Brabant, Belgium
CHRU Lille - Hopital Claude Huriez /ID# 252054Recruiting
Lille, Nord, France
IUCT Oncopole /ID# 259409Recruiting
Toulouse, Occitanie, France
Charite Universitaetsmedizin Berlin Campus Virchow-Klinikum /ID# 252062Completed
Berlin, Germany
Shamir Medical Center /ID# 257711Recruiting
Beer Ya'akov, Central District, Israel
Hadassah Medical Center-Hebrew University /ID# 251441Recruiting
Jerusalem, Jerusalem, Israel
The Chaim Sheba Medical Center /ID# 251442Recruiting
Ramat Gan, Tel Aviv, Israel
Rabin Medical Center. /ID# 257665Recruiting
Petah Tikva, Israel
Seoul National University Hospital /ID# 266340Recruiting
Seoul, Seoul Teugbyeolsi, South Korea
Asan Medical Center /ID# 266341Recruiting
Seoul, Seoul Teugbyeolsi, South Korea
Samsung Medical Center /ID# 266415Recruiting
Seoul, Seoul Teugbyeolsi, South Korea
Institut Català d'Oncologia (ICO) - L'Hospitalet /ID# 246537Recruiting
L'Hospitalet de Llobregat, Barcelona, Spain
Hospital Universitario Vall de Hebron /ID# 245475Recruiting
Barcelona, Spain
Hospital Clinic de Barcelona /ID# 246543Recruiting
Barcelona, Spain
Hospital Universitario Ramon y Cajal /ID# 246540Completed
Madrid, Spain
Hospital Universitario 12 de Octubre /ID# 246538Recruiting
Madrid, Spain
China Medical University Hospital /ID# 266414Recruiting
Taichung, Taiwan
National Taiwan University Hospital /ID# 266343Recruiting
Taipei, Taiwan
Leeds Teaching Hospitals NHS Trust /ID# 245470Recruiting
Leeds, West Yorkshire, United Kingdom
The Royal Marsden NHS Foundation Trust /ID# 250324Recruiting
London, United Kingdom
The Christie Hospital /ID# 250325Recruiting
Manchester, United Kingdom