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RECRUITING

NCT05618028

PHASE1

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

Sponsor: AbbVie

View on ClinicalTrials.gov

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.

Official title: A First-in-Human Study of ABBV-525 (MALT1 Inhibitor) in B-Cell Malignancies

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

150

Start Date

2023-04-04

Completion Date

2029-07

Last Updated

2026-02-12

Healthy Volunteers

Conditions

Diffuse Large B-Cell Lymphoma Chronic Lymphocytic Leukemia B Cell Malignancies Non-Hodgkin's Lymphoma

Interventions

DRUG

ABBV-525

Oral; Tablet

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.

Locations (39)

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

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

China Medical University Hospital /ID# 266414

Taichung, Taiwan

National Taiwan University Hospital /ID# 266343

Taipei, Taiwan

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

Clinical Research Directory

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

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (39)