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

Last updated: February 10, 2026
Sponsor: AbbVie
Overall Status: Active - Recruiting

Phase

1

Condition

Non-hodgkin's Lymphoma

Lymphoma, B-cell

Hematologic Cancer

Treatment

ABBV-525

Clinical Study ID

NCT05618028
M23-324
2022-503136-13
  • Ages > 18
  • All Genders

Study Summary

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

Inclusion Criteria:

  • Dose Escalation (Part 1) Only: Participants with a documented diagnosis of one ofthe following third line or later of treatment (3L)+ mature B-cell malignancies,from the World Health Organization (WHO)-defined histologies as defined in theprotocol.

  • Dose Optimization (Part 2) Only: Participants with documented diagnosis of chroniclymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL) with histology based onWHO criteria, with measurable disease requiring treatment as defined by theInternational 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, withmeasurable 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 beforestudy enrollment.

  • Participants with prior central nervous system (CNS) disease that has beeneffectively treated may be eligible.

  • Participants with resolved coronavirus disease 2019 (COVID-19) infection areeligible.

Exclusion

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 firstdose 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 theprotocol.

  • Known history of human immunodeficiency virus (HIV).

  • Known active COVID-19 infection. Participant must not have signs/symptoms associatedwith COVID-19 infection or known exposure to a confirmed case of COVID-19 infectionduring screening. If participant has signs/symptoms suggestive of COVID-19infection, the participant must have a negative molecular (e.g., polymerase chainreaction) test or 3 negative antigen test results at least 24 hours apart.

Study Design

Total Participants: 150
Treatment Group(s): 1
Primary Treatment: ABBV-525
Phase: 1
Study Start date:
April 04, 2023
Estimated Completion Date:
July 31, 2029

Connect with a study center

  • Paratus Clinical Research Woden /ID# 247859

    Phillip, Australian Capital Territory 2606
    Australia

    Site Not Available

  • Liverpool Hospital /ID# 260191

    Liverpool, New South Wales 2170
    Australia

    Site Not Available

  • Liverpool Hospital /ID# 260191

    Liverpool 2159851, New South Wales 2155400 2170
    Australia

    Active - Recruiting

  • Orange Health Service /ID# 260473

    Orange 2154219, New South Wales 2155400 2800
    Australia

    Active - Recruiting

  • Monash Health - Monash Medical Centre /ID# 246366

    Clayton, Victoria 3168
    Australia

    Site Not Available

  • Monash University /ID# 246366

    Clayton, Victoria 3168
    Australia

    Active - Recruiting

  • Alfred Health /ID# 248592

    Melbourne, Victoria 3004
    Australia

    Active - Recruiting

  • The Alfred Hospital /ID# 248592

    Melbourne, Victoria 3004
    Australia

    Site Not Available

  • Monash Health - Monash Medical Centre /ID# 246366

    Clayton 2171400, Victoria 2145234 3168
    Australia

    Active - Recruiting

  • The Alfred Hospital /ID# 248592

    Melbourne 2158177, Victoria 2145234 3004
    Australia

    Active - Recruiting

  • UZ Gent /ID# 246462

    Gent, Oost-Vlaanderen 9000
    Belgium

    Site Not Available

  • UZ Gent /ID# 246462

    Ghent 2797656, Oost-Vlaanderen 9000
    Belgium

    Active - Recruiting

  • Universitair Ziekenhuis Leuven /ID# 246461

    Leuven, Vlaams-Brabant 3000
    Belgium

    Site Not Available

  • Universitair Ziekenhuis Leuven /ID# 246461

    Leuven 2792482, Vlaams-Brabant 3000
    Belgium

    Active - Recruiting

  • CHRU Lille - Hopital Claude Huriez /ID# 252054

    Lille, Nord 59037
    France

    Site Not Available

  • CHRU Lille - Hopital Claude Huriez /ID# 252054

    Lille 2998324, Nord 59037
    France

    Active - Recruiting

  • CHU Toulouse /ID# 252193

    Toulouse, Occitanie 31300
    France

    Site Not Available

  • IUCT Oncopole /ID# 259409

    Toulouse Cedex 9, Occitanie 31059
    France

    Site Not Available

  • IUCT Oncopole /ID# 259409

    Toulouse 2972315, Occitanie 11071623 31059
    France

    Active - Recruiting

  • Charite Universitaetsklinikum Berlin - Campus Virchow /ID# 252062

    Berlin, 13353
    Germany

    Active - Recruiting

  • Charite Universitaetsmedizin Berlin Campus Virchow-Klinikum /ID# 252062

    Berlin, 13353
    Germany

    Site Not Available

  • Charite Universitaetsmedizin Berlin Campus Virchow-Klinikum /ID# 252062

    Berlin 2950159, 13353
    Germany

    Completed

  • University of Cologne /ID# 246646

    Cologne, 50923
    Germany

    Site Not Available

  • Shamir Medical Center /ID# 257711

    Beer Ya'akov, Central District 294904 70300
    Israel

    Active - Recruiting

  • Shamir Medical Center (Assaf Harofeh) /ID# 257711

    Be'er Yaakov, HaMerkaz 70300
    Israel

    Site Not Available

  • Hadassah Medical Center-Hebrew University /ID# 251441

    Jerusalem 281184, Jerusalem 293198 91120
    Israel

    Active - Recruiting

  • The Chaim Sheba Medical Center /ID# 251442

    Ramat Gan 293788, Tel Aviv 293396 5265601
    Israel

    Active - Recruiting

  • The Chaim Sheba Medical Center /ID# 251442

    Ramat Gan, Tel-Aviv 5265601
    Israel

    Site Not Available

  • Hadassah Medical Center-Hebrew University /ID# 251441

    Jerusalem, Yerushalayim 91120
    Israel

    Site Not Available

  • Rabin Medical Center /ID# 257665

    Haifa, 4941492
    Israel

    Site Not Available

  • Rabin Medical Center /ID# 257665

    Petah Tikva, 4941492
    Israel

    Site Not Available

  • Rabin Medical Center /ID# 257665

    Petah Tikva 293918, 4941492
    Israel

    Active - Recruiting

  • Rabin Medical Center. /ID# 257665

    Petah Tikva 293918, 4941492
    Israel

    Active - Recruiting

  • Asan Medical Center /ID# 266341

    Seoul, Seoul Teugbyeolsi 05505
    Korea, Republic of

    Site Not Available

  • Asan Medical Center /ID# 266341

    Seoul 1835848, Seoul Teugbyeolsi 05505
    South Korea

    Active - Recruiting

  • Samsung Medical Center /ID# 266415

    Seoul 1835848, Seoul Teugbyeolsi 06351
    South Korea

    Active - Recruiting

  • Seoul National University Hospital /ID# 266340

    Seoul 1835848, Seoul Teugbyeolsi 03080
    South Korea

    Active - Recruiting

  • Institut Català d'Oncologia (ICO) - L'Hospitalet /ID# 246537

    L'Hospitalet de Llobregat, Barcelona 08907
    Spain

    Site Not Available

  • Institut Català d'Oncologia (ICO) - L'Hospitalet /ID# 246537

    L'Hospitalet de Llobregat 3120619, Barcelona 08907
    Spain

    Active - Recruiting

  • Hospital Clinic de Barcelona /ID# 246543

    Barcelona, 08036
    Spain

    Site Not Available

  • Hospital Universitario Vall d'Hebron /ID# 245475

    Barcelona, 08035
    Spain

    Active - Recruiting

  • Institut Catala d'Oncologia -Hospital Duran i Reynals /ID# 246537

    Barcelona, 08907
    Spain

    Site Not Available

  • Hospital Clinic de Barcelona /ID# 246543

    Barcelona 3128760, 08036
    Spain

    Active - Recruiting

  • Hospital Universitario Vall de Hebron /ID# 245475

    Barcelona 3128760, 08035
    Spain

    Active - Recruiting

  • Hospital Universitario 12 de Octubre /ID# 246538

    Madrid, 28041
    Spain

    Site Not Available

  • Hospital Universitario Ramon y Cajal /ID# 246540

    Madrid, 28034
    Spain

    Active - Recruiting

  • Hospital Universitario 12 de Octubre /ID# 246538

    Madrid 3117735, 28041
    Spain

    Active - Recruiting

  • Hospital Universitario Ramon y Cajal /ID# 246540

    Madrid 3117735, 28034
    Spain

    Completed

  • National Taiwan University Hospital /ID# 266343

    Taipei City, Taipei 7280290 100
    Taiwan

    Site Not Available

  • China Medical University Hospital /ID# 266414

    Taichung 1668399, 40447
    Taiwan

    Active - Recruiting

  • National Taiwan University Hospital /ID# 266343

    Taipei 1668341, 100
    Taiwan

    Active - Recruiting

  • Leeds Teaching Hospitals NHS Trust /ID# 245470

    Leeds, West Yorkshire LS9 7TF
    United Kingdom

    Site Not Available

  • Leeds Teaching Hospitals NHS Trust /ID# 245470

    Leeds 2644688, West Yorkshire LS9 7TF
    United Kingdom

    Active - Recruiting

  • The Royal Marsden NHS Foundation Trust /ID# 250324

    London, SW3 6JJ
    United Kingdom

    Site Not Available

  • The Royal Marsden NHS Foundation Trust /ID# 250324

    London 2643743, SW3 6JJ
    United Kingdom

    Active - Recruiting

  • The Christie Hospital /ID# 250325

    Manchester, M20 4BX
    United Kingdom

    Site Not Available

  • The Christie Hospital /ID# 250325

    Manchester 2643123, M20 4BX
    United Kingdom

    Active - Recruiting

  • University of California Los Angeles /ID# 246357

    Los Angeles, California 90095
    United States

    Site Not Available

  • University of California Los Angeles /ID# 246357

    Los Angeles 5368361, California 5332921 90095
    United States

    Active - Recruiting

  • University of California Los Angeles Medical Center /ID# 246357

    Los Angeles 5368361, California 5332921 90095
    United States

    Active - Recruiting

  • Yale University School of Medicine /ID# 259081

    New Haven, Connecticut 06510
    United States

    Site Not Available

  • Yale University School of Medicine /ID# 259081

    New Haven 4839366, Connecticut 4831725 06510
    United States

    Active - Recruiting

  • Mount Sinai Medical Center-Miami Beach /ID# 248251

    Miami Beach, Florida 33140-2948
    United States

    Site Not Available

  • Mount Sinai Medical Center-Miami Beach /ID# 248251

    Miami Beach 4164143, Florida 4155751 33140-2948
    United States

    Completed

  • Fort Wayne Medical Oncology and Hematology, Inc /ID# 250113

    Fort Wayne, Indiana 46804
    United States

    Site Not Available

  • Indiana University Melvin and Bren Simon Comprehensive Cancer Center /ID# 259872

    Indianapolis, Indiana 46202-5116
    United States

    Site Not Available

  • Fort Wayne Medical Oncology and Hematology, Inc /ID# 250113

    Fort Wayne 4920423, Indiana 4921868 46804
    United States

    Active - Recruiting

  • Indiana University Melvin and Bren Simon Comprehensive Cancer Center /ID# 259872

    Indianapolis 4259418, Indiana 4921868 46202-5116
    United States

    Active - Recruiting

  • Norton Healthcare /ID# 246362

    Louisville, Kentucky 40207-4700
    United States

    Site Not Available

  • Tulane Cancer Center Clinic /ID# 249586

    New Orleans, Louisiana 70112
    United States

    Site Not Available

  • Tulane Cancer Center Clinic /ID# 249586

    New Orleans 4335045, Louisiana 4331987 70112
    United States

    Completed

  • Cancer & Hematology Centers /ID# 252359

    Grand Rapids, Michigan 49503
    United States

    Active - Recruiting

  • START Midwest /ID# 252359

    Grand Rapids, Michigan 49546
    United States

    Site Not Available

  • START Midwest /ID# 252359

    Grand Rapids 4994358, Michigan 5001836 49546
    United States

    Active - Recruiting

  • Memorial Sloan Kettering Cancer Center-Koch Center /ID# 245459

    New York, New York 10065-6007
    United States

    Site Not Available

  • Memorial Sloan Kettering Cancer Center-Koch Center /ID# 245459

    New York 5128581, New York 5128638 10065-6007
    United States

    Active - Recruiting

  • Levine Cancer Ins, Carolina Me /ID# 246363

    Charlotte, North Carolina 28204
    United States

    Active - Recruiting

  • Levine Cancer Institute /ID# 246363

    Charlotte, North Carolina 28204
    United States

    Site Not Available

  • Atrium Health Levine Cancer Institute /ID# 246363

    Charlotte 4460243, North Carolina 4482348 28204
    United States

    Active - Recruiting

  • Levine Cancer Institute /ID# 246363

    Charlotte 4460243, North Carolina 4482348 28204
    United States

    Active - Recruiting

  • University Of Cincinnati Medical Center /ID# 262288

    Cincinnati, Ohio 45219
    United States

    Site Not Available

  • University of Cincinnati /ID# 262288

    Cincinnati, Ohio 45267-0585
    United States

    Active - Recruiting

  • University Of Cincinnati Medical Center /ID# 262288

    Cincinnati 4508722, Ohio 5165418 45219
    United States

    Completed

  • University of Texas MD Anderson Cancer Center /ID# 245463

    Houston, Texas 77030
    United States

    Site Not Available

  • University of Texas MD Anderson Cancer Center /ID# 245463

    Houston 4699066, Texas 4736286 77030
    United States

    Active - Recruiting

  • University of Utah Health Hospital /ID# 259924

    Salt Lake City, Utah 84132
    United States

    Site Not Available

  • University of Utah Health Hospital /ID# 259924

    Salt Lake City 5780993, Utah 5549030 84132
    United States

    Active - Recruiting

  • Northwest Medical Specialties - Tacoma /ID# 260376

    Tacoma, Washington 98405
    United States

    Site Not Available

  • Northwest Medical Specialties - Tacoma /ID# 260376

    Tacoma 5812944, Washington 5815135 98405
    United States

    Active - Recruiting

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