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

NCT05618028 | Active Not Recruiting Phase 1 DMC FDA Drug

• 3 other identifiers: M23-3242022-503136-132022-503136-13-00
• Study Type: interventional
• Target: 78
• Locations: 10 countries
• Sites: 39

Brief 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.

Conditions

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

Keywords

Diffuse Large B-Cell Lymphoma; B-cell Malignancies; Chronic Lymphocytic Leukemia; Non-Hodgkin's Lymphoma; ABBV-525; Cancer

Outcome Measures

Primary Outcomes (9)

• Number of Participants With Adverse Events (AE)

  An AE is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. A serious adverse event (SAE) is defined as any untoward medical occurrence, whether associated with study drug or not, that results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is an important medical event requiring medical or surgical intervention to prevent serious outcome.

  Up to Approximately 64 Months

• Number of Participants With Dose-Limiting Toxicities (DLT)

  A DLT is defined as any AE for which a clear alternative cause cannot be established (eg, attributed to the disease under study, another disease, or to a concomitant medication by the study investigators or medical monitor).

  Up to Approximately 28 Days

• Number of Tumor Lysis Syndrome (TLS)

  TLS is confirmed by evaluation of electrolyte and fluid status and renal status including urine output.

  Up to Approximately 64 Months

• Number of Participants With Clinically Significant Changes From Baseline in Clinical Laboratory Parameters

  Clinical laboratory parameters included tests of hematology, chemistry, urinalysis and prolactin. The investigator will assess the results for clinical significance.

  Up to Approximately 64 Months

• Number of Participants With Clinically Significant Changes From Baseline in Vital Sign Parameters

  Vital sign parameters included body temperature, systolic and diastolic blood pressure, pulse rate, and respiratory rate. The investigator will assess the results for clinical significance.

  Up to Approximately 64 Months

• Number of Participants With Clinically Significant Changes From Baseline in Electrocardiograms (ECG)

  A standard 12-lead ECG will be performed. The investigator will assess the results for clinical significance.

  Up to Approximately 64 Months

• Maximum Observed Plasma Concentration (Cmax) of ABBV-525

  Maximum observed plasma concentration of ABBV-525.

  Up to 12 Months

• Time to Cmax (Tmax) of ABBV-525

  Time to Cmax of ABBV-525.

  Up to 12 Months

• Area Under the Plasma Concentration-Time Curve (AUC) of ABBV-525

  Area under the plasma concentration-time curve of ABBV-525.

  Up to 12 Months

Secondary Outcomes (2)

• Overall Response Rate (ORR)

  Up to Approximately 64 Months

• Duration of Response (DOR)

  Up to Approximately 64 Months

Study Arms (3)

ABBV-525 Dose Escalation

EXPERIMENTAL

Participants will receive escalating doses of ABBV-525 until doses for optimization are determined, as part of an approximately 64 month study period.

Drug: ABBV-525

ABBV-525 Dose Optimization

EXPERIMENTAL

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.

Drug: ABBV-525

ABBV-525 Dose Expansion

EXPERIMENTAL

Participants will receive the RP2D dose of ABBV-525, as part of an approximately 64 month study period.

Drug: ABBV-525

Interventions

ABBV-525 DRUG

Oral; Tablet

ABBV-525 Dose Escalation; ABBV-525 Dose Expansion; ABBV-525 Dose Optimization

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• AbbVie: lead

Study Sites (39)

University of California Los Angeles Medical Center /ID# 246357

Los Angeles, California, 90095, United States

Location

Yale University School of Medicine /ID# 259081

New Haven, Connecticut, 06510, United States

Location

Mount Sinai Medical Center-Miami Beach /ID# 248251

Miami Beach, Florida, 33140-2948, United States

Location

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

Fort Wayne, Indiana, 46804, United States

Location

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

Indianapolis, Indiana, 46202-5116, United States

Location

Tulane Cancer Center Clinic /ID# 249586

New Orleans, Louisiana, 70112, United States

Location

START Midwest /ID# 252359

Grand Rapids, Michigan, 49546, United States

Location

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

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

Location

Atrium Health Levine Cancer Institute /ID# 246363

Charlotte, North Carolina, 28204, United States

Location

University Of Cincinnati Medical Center /ID# 262288

Cincinnati, Ohio, 45219, United States

Location

University of Texas MD Anderson Cancer Center /ID# 245463

Houston, Texas, 77030, United States

Location

University of Utah Health Hospital /ID# 259924

Salt Lake City, Utah, 84132, United States

Location

Northwest Medical Specialties - Tacoma /ID# 260376

Tacoma, Washington, 98405, United States

Location

Bankstown-Lidcombe Hospital /ID# 260191

Bankstown, New South Wales, 2200, Australia

Location

Orange Health Service /ID# 260473

Orange, New South Wales, 2800, Australia

Location

Monash Health - Monash Medical Centre /ID# 246366

Clayton, Victoria, 3168, Australia

Location

The Alfred Hospital /ID# 248592

Melbourne, Victoria, 3004, Australia

Location

UZ Gent /ID# 246462

Ghent, Oost-Vlaanderen, 9000, Belgium

Location

Universitair Ziekenhuis Leuven /ID# 246461

Leuven, Vlaams-Brabant, 3000, Belgium

Location

CHRU Lille - Hopital Claude Huriez /ID# 252054

Lille, Nord, 59037, France

Location

IUCT Oncopole /ID# 259409

Toulouse, Occitanie, 31059, France

Location

Charite Universitaetsmedizin Berlin Campus Virchow-Klinikum /ID# 252062

Berlin, 13353, Germany

Location

Shamir Medical Center /ID# 257711

Beer Ya'akov, Central District, 70300, Israel

Location

Rabin Medical Center. /ID# 257665

Petah Tikva, Central District, 4941492, Israel

Location

Hadassah Medical Center-Hebrew University /ID# 251441

Jerusalem, Jerusalem, 91120, Israel

Location

The Chaim Sheba Medical Center /ID# 251442

Ramat Gan, Tel Aviv, 5265601, Israel

Location

Seoul National University Hospital /ID# 266340

Seoul, Seoul Teugbyeolsi, 03080, South Korea

Location

Asan Medical Center /ID# 266341

Seoul, Seoul Teugbyeolsi, 05505, South Korea

Location

Samsung Medical Center /ID# 266415

Seoul, Seoul Teugbyeolsi, 06351, South Korea

Location

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

L'Hospitalet de Llobregat, Barcelona, 08907, Spain

Location

Hospital Universitario Vall de Hebron /ID# 245475

Barcelona, 08035, Spain

Location

Hospital Clinic de Barcelona /ID# 246543

Barcelona, 08036, Spain

Location

Hospital Universitario Ramon y Cajal /ID# 246540

Madrid, 28034, Spain

Location

Hospital Universitario 12 de Octubre /ID# 246538

Madrid, 28041, Spain

Location

China Medical University Hospital /ID# 266414

Taichung, 40447, Taiwan

Location

National Taiwan University Hospital /ID# 266343

Taipei, 100, Taiwan

Location

Leeds Teaching Hospitals NHS Trust /ID# 245470

Leeds, West Yorkshire, LS9 7TF, United Kingdom

Location

The Royal Marsden NHS Foundation Trust /ID# 250324

London, SW3 6JJ, United Kingdom

Location

The Christie Hospital /ID# 250325

Manchester, M20 4BX, United Kingdom

Location

MeSH Terms

Conditions

Lymphoma, Large B-Cell, Diffuse; Leukemia, Lymphocytic, Chronic, B-Cell; Lymphoma, Non-Hodgkin; Neoplasms

Condition Hierarchy (Ancestors)

Lymphoma, B-Cell; Lymphoma; Neoplasms by Histologic Type; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Leukemia, B-Cell; Leukemia, Lymphoid; Leukemia; Hematologic Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• ABBVIE INC.

  AbbVie

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 14, 2022
• First Posted: November 16, 2022
• Study Start: April 4, 2023
• Primary Completion (Estimated): July 1, 2029
• Study Completion (Estimated): July 1, 2029
• Last Updated: May 4, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

IL (4); AU (4); BE (2); FR (2); KR (3); TW (2); ES (5); US (13); DE (1); GB (3)