Study to Evaluate Adverse Events and Change in Disease Activity in Adult Participants With B-Cell… (NCT05618028) | Clinical Trial Compass
Active — Not RecruitingPhase 1
Study to Evaluate Adverse Events and Change in Disease Activity in Adult Participants With B-Cell Malignancies Receiving Oral ABBV-525 Tablets
United States, Australia, Belgium78 participantsStarted 2023-04-04
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 pri…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since ABBV-525 is being studied in a Phase 1 trial that is primarily focused on finding a safe dose and identifying side effects — not yet proving it works — what does that mean for weighing the potential risks against the benefits for my specific situation?
2The trial is specifically measuring dose-limiting toxicities and tumor lysis syndrome as key safety signals — how serious are those risks for someone with my diagnosis, and what monitoring or precautions would be in place to catch them early?
3This trial is no longer actively enrolling new participants — does that affect whether there are any remaining spots, and are there similar early-phase studies of ABBV-525 or other experimental drugs in the same class that might be an option for me?
4Given that the trial covers several different B-cell malignancies including diffuse large B-cell lymphoma and chronic lymphocytic leukemia, how would my specific diagnosis and current disease status factor into whether this kind of study would even be appropriate to discuss?
5Before considering an experimental Phase 1 trial like this one, are there standard approved treatments I should try first, or is my situation one where joining an early-phase study might actually make sense as a next step?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of Participants With Adverse Events (AE)
Timeframe: Up to Approximately 64 Months
2
Number of Participants With Dose-Limiting Toxicities (DLT)
Timeframe: Up to Approximately 28 Days
3
Number of Tumor Lysis Syndrome (TLS)
Timeframe: Up to Approximately 64 Months
4
Number of Participants With Clinically Significant Changes From Baseline in Clinical Laboratory Parameters
Timeframe: Up to Approximately 64 Months
5
Number of Participants With Clinically Significant Changes From Baseline in Vital Sign Parameters
Timeframe: Up to Approximately 64 Months
6
Number of Participants With Clinically Significant Changes From Baseline in Electrocardiograms (ECG)
Timeframe: Up to Approximately 64 Months
7
Maximum Observed Plasma Concentration (Cmax) of ABBV-525