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

Last updated: April 14, 2025
Sponsor: AbbVie
Overall Status: Active - Recruiting

Phase

1

Condition

Non-hodgkin's Lymphoma

Lymphoma

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 100 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) who are 3L+, +/- cysteine-to-serine point mutation atresidue 481 of BTK-domain active site (C481S with histology based on WHO criteria,with measurable disease requiring treatment as defined by the International Workshopon Chronic Lymphocytic Leukemia (iwCLL).

  • Dose Expansion (Part 3) Only: Participants with documented diagnosis of non-germinalcenter B cell (GCB) Diffuse large B-cell lymphoma (DLBCL) who are 3L+ chimericantigen receptor T-cells (CAR-T)/Hematopoietic cell transplant (HCT)relapsed/refractory (R/R) and/or ineligible with histology based on WHO criteria,with measurable disease requiring treatment.

  • Participant has an Eastern Cooperative Oncology Group (ECOG) Performance Status (PS)of 0 or 1.

  • 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 hepatitis B or C infection.

  • 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 (eg, polymerase chainreaction) test or 3 negative antigen test results at least 24 hours apart.

Study Design

Total Participants: 100
Treatment Group(s): 1
Primary Treatment: ABBV-525
Phase: 1
Study Start date:
April 04, 2023
Estimated Completion Date:
June 30, 2027

Connect with a study center

  • Paratus Clinical Research Woden /ID# 247859

    Phillip, Australian Capital Territory 2606
    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

    Active - Recruiting

  • UZ Gent /ID# 246462

    Gent, Oost-Vlaanderen 9000
    Belgium

    Active - Recruiting

  • Universitair Ziekenhuis Leuven /ID# 246461

    Leuven, Vlaams-Brabant 3000
    Belgium

    Active - Recruiting

  • CHRU Lille - Hopital Claude Huriez /ID# 252054

    Lille, 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

    Active - Recruiting

  • Charite Universitaetsklinikum Berlin - Campus Virchow /ID# 252062

    Berlin, 13353
    Germany

    Active - Recruiting

  • University of Cologne /ID# 246646

    Cologne, 50923
    Germany

    Site Not Available

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

    Be'er Yaakov, HaMerkaz 70300
    Israel

    Site Not Available

  • Shamir Medical Center /ID# 257711

    Beer Ya'akov, HaMerkaz 70300
    Israel

    Active - Recruiting

  • The Chaim Sheba Medical Center /ID# 251442

    Ramat Gan, Tel-Aviv 5265601
    Israel

    Active - Recruiting

  • Hadassah Medical Center-Hebrew University /ID# 251441

    Jerusalem, Yerushalayim 91120
    Israel

    Active - Recruiting

  • Rabin Medical Center /ID# 257665

    Haifa, 4941492
    Israel

    Site Not Available

  • Rabin Medical Center /ID# 257665

    Petah Tikva, 4941492
    Israel

    Active - Recruiting

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

    L'Hospitalet de Llobregat, Barcelona 08907
    Spain

    Active - Recruiting

  • Hospital Clinic de Barcelona /ID# 246543

    Barcelona, 08036
    Spain

    Active - Recruiting

  • 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 Universitario 12 de Octubre /ID# 246538

    Madrid, 28041
    Spain

    Active - Recruiting

  • Hospital Universitario Ramon y Cajal /ID# 246540

    Madrid, 28034
    Spain

    Active - Recruiting

  • Leeds Teaching Hospitals NHS Trust /ID# 245470

    Leeds, West Yorkshire LS9 7TF
    United Kingdom

    Active - Recruiting

  • The Royal Marsden NHS Foundation Trust /ID# 250324

    London, SW3 6JJ
    United Kingdom

    Active - Recruiting

  • The Christie Hospital /ID# 250325

    Manchester, M20 4BX
    United Kingdom

    Active - Recruiting

  • University of California Los Angeles /ID# 246357

    Los Angeles, California 90095
    United States

    Active - Recruiting

  • Yale University School of Medicine /ID# 259081

    New Haven, Connecticut 06510
    United States

    Active - Recruiting

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

    Miami Beach, Florida 33140-2948
    United States

    Active - Recruiting

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

    Fort Wayne, Indiana 46804
    United States

    Active - Recruiting

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

    Indianapolis, Indiana 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

    Completed

  • Cancer & Hematology Centers /ID# 252359

    Grand Rapids, Michigan 49503
    United States

    Active - Recruiting

  • START Midwest /ID# 252359

    Grand Rapids, Michigan 49546
    United States

    Active - Recruiting

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

    New York, New York 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

    Active - Recruiting

  • University Of Cincinnati Medical Center /ID# 262288

    Cincinnati, Ohio 45219
    United States

    Active - Recruiting

  • University of Cincinnati /ID# 262288

    Cincinnati, Ohio 45267-0585
    United States

    Active - Recruiting

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

    Houston, Texas 77030
    United States

    Active - Recruiting

  • University of Utah Health Hospital /ID# 259924

    Salt Lake City, Utah 84132
    United States

    Active - Recruiting

  • Northwest Medical Specialties - Tacoma /ID# 260376

    Tacoma, Washington 98405
    United States

    Active - Recruiting

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