Study to Evaluate Adverse Events and Change in Disease Activity in Adult Participants With B-Cell Malignancies Receiving Oral ABBV-525 Tablets

Running, not enrolling · Phase 1

Conditions studied: Diffuse Large B-Cell Lymphoma, Chronic Lymphocytic Leukemia, B Cell Malignancies, Non-Hodgkin's Lymphoma

In brief

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.

Key facts

Study ID: NCT05618028
Run by: AbbVie
People needed: 78
Starts: 2023-04-04
Expected to finish: 2029-07-01
Last updated by the study team: 2026-05-04

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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.

You may not qualify if…

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.

Where it is running

University of California Los Angeles Medical Center /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
Bankstown-Lidcombe Hospital /ID# 260191 — Bankstown, 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
Rabin Medical Center. /ID# 257665 — Petah Tikva, Central District, Israel
Hadassah Medical Center-Hebrew University /ID# 251441 — Jerusalem, Jerusalem, Israel

Full record on ClinicalTrials.gov

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