Language: BG BG
← Back to results
Recruiting Phase 1 NCT05618028

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

Phase 1 – testing safety in a small group of people
Conditions: Diffuse Large B-Cell Lymphoma Chronic Lymphocytic Leukemia B Cell Malignancies Non-Hodgkin's Lymphoma

Sponsor: AbbVie

trial.available_in: БГ
Overview
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.
Who can participate
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 10
Australia (1)
Liverpool Hospital /ID# 260191
Liverpool , New South Wales
Belgium (1)
UZ Gent /ID# 246462
Ghent , Oost-Vlaanderen
France (1)
CHRU Lille - Hopital Claude Huriez /ID# 252054
Lille , Nord
Germany (1)
Charite Universitaetsmedizin Berlin Campus Virchow-Klinikum /ID# 252062
Berlin
COMPLETED
Israel (1)
Shamir Medical Center /ID# 257711
Beer Ya'akov , Central District
South Korea (1)
Seoul National University Hospital /ID# 266340
Seoul , Seoul Teugbyeolsi
Spain (1)
Institut Català d'Oncologia (ICO) - L'Hospitalet /ID# 246537
L'Hospitalet de Llobregat , Barcelona
Taiwan (1)
China Medical University Hospital /ID# 266414
Taichung
United Kingdom (1)
Leeds Teaching Hospitals NHS Trust /ID# 245470
Leeds , West Yorkshire
United States (1)
University of California Los Angeles Medical Center /ID# 246357
Los Angeles , California
Technical details
Status
Recruiting
Phase
Phase 1
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Healthy volunteers
No
Start date
04.04.2023
Completion date
01.07.2029
Registry ID
NCT05618028
Source
anzctr
trial.inquiry_btn

Information is automatically extracted from ClinicalTrials.gov. Consult your doctor before taking action.