Study to Evaluate Adverse Events and Change in Disease Activity in Adult Participants With B-Cell Malignancies Receiving Oral ABBV-525 Tablets
NCT ID: NCT05618028
Last Updated: 2025-12-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
150 participants
INTERVENTIONAL
2023-04-04
2029-07-31
Brief Summary
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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.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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ABBV-525 Dose Escalation
Participants will receive escalating doses of ABBV-525 until doses for optimization are determined, as part of an approximately 64 month study period.
ABBV-525
Oral; Tablet
ABBV-525 Dose Optimization
Participants will receive one of two doses of ABBV-525 until the recommended phase 2 dose (RP2D) is determined, as part of an approximately 64 month study period.
ABBV-525
Oral; Tablet
ABBV-525 Dose Expansion
Participants will receive the RP2D dose of ABBV-525, as part of an approximately 64 month study period.
ABBV-525
Oral; Tablet
Interventions
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ABBV-525
Oral; Tablet
Eligibility Criteria
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Inclusion Criteria
* 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 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.
18 Years
ALL
No
Sponsors
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AbbVie
INDUSTRY
Responsible Party
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Principal Investigators
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ABBVIE INC.
Role: STUDY_DIRECTOR
AbbVie
Locations
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University of California Los Angeles /ID# 246357
Los Angeles, California, United States
Yale University School of Medicine /ID# 259081
New Haven, Connecticut, United States
Mount Sinai Medical Center-Miami Beach /ID# 248251
Miami Beach, Florida, United States
Fort Wayne Medical Oncology and Hematology, Inc /ID# 250113
Fort Wayne, Indiana, United States
Indiana University Melvin and Bren Simon Comprehensive Cancer Center /ID# 259872
Indianapolis, Indiana, United States
Tulane Cancer Center Clinic /ID# 249586
New Orleans, Louisiana, United States
START Midwest /ID# 252359
Grand Rapids, Michigan, United States
Memorial Sloan Kettering Cancer Center-Koch Center /ID# 245459
New York, New York, United States
Atrium Health Levine Cancer Institute /ID# 246363
Charlotte, North Carolina, United States
University Of Cincinnati Medical Center /ID# 262288
Cincinnati, Ohio, United States
University of Texas MD Anderson Cancer Center /ID# 245463
Houston, Texas, United States
University of Utah Health Hospital /ID# 259924
Salt Lake City, Utah, United States
Northwest Medical Specialties - Tacoma /ID# 260376
Tacoma, Washington, United States
Liverpool Hospital /ID# 260191
Liverpool, New South Wales, Australia
Orange Health Service /ID# 260473
Orange, New South Wales, Australia
Monash Health - Monash Medical Centre /ID# 246366
Clayton, Victoria, Australia
The Alfred Hospital /ID# 248592
Melbourne, Victoria, Australia
UZ Gent /ID# 246462
Ghent, Oost-Vlaanderen, Belgium
Universitair Ziekenhuis Leuven /ID# 246461
Leuven, Vlaams-Brabant, Belgium
CHRU Lille - Hopital Claude Huriez /ID# 252054
Lille, Nord, France
IUCT Oncopole /ID# 259409
Toulouse, Occitanie, France
Charite Universitaetsmedizin Berlin Campus Virchow-Klinikum /ID# 252062
Berlin, , Germany
Shamir Medical Center /ID# 257711
Beer Ya'akov, Central District, Israel
Hadassah Medical Center-Hebrew University /ID# 251441
Jerusalem, Jerusalem, Israel
The Chaim Sheba Medical Center /ID# 251442
Ramat Gan, Tel Aviv, Israel
Rabin Medical Center. /ID# 257665
Petah Tikva, , Israel
Seoul National University Hospital /ID# 266340
Seoul, Seoul Teugbyeolsi, South Korea
Asan Medical Center /ID# 266341
Seoul, Seoul Teugbyeolsi, South Korea
Samsung Medical Center /ID# 266415
Seoul, Seoul Teugbyeolsi, South Korea
Institut Català d'Oncologia (ICO) - L'Hospitalet /ID# 246537
L'Hospitalet de Llobregat, Barcelona, Spain
Hospital Universitario Vall de Hebron /ID# 245475
Barcelona, , Spain
Hospital Clinic de Barcelona /ID# 246543
Barcelona, , Spain
Hospital Universitario Ramon y Cajal /ID# 246540
Madrid, , Spain
Hospital Universitario 12 de Octubre /ID# 246538
Madrid, , Spain
Leeds Teaching Hospitals NHS Trust /ID# 245470
Leeds, West Yorkshire, United Kingdom
The Royal Marsden NHS Foundation Trust /ID# 250324
London, , United Kingdom
The Christie Hospital /ID# 250325
Manchester, , United Kingdom
Countries
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Central Contacts
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Other Identifiers
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M23-324
Identifier Type: -
Identifier Source: org_study_id
2022-503136-13
Identifier Type: OTHER
Identifier Source: secondary_id