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

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

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) who are 3L+, +/- cysteine-to-serine point mutation at residue 481 of BTK-domain active site (C481S 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 non-germinal center B cell (GCB) Diffuse large B-cell lymphoma (DLBCL) who are 3L+ chimeric antigen 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 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 hepatitis B or C infection. - 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 (eg, polymerase chain reaction) test or 3 negative antigen test results at least 24 hours apart.

Exclusion Criteria

Not provided

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of Participants With Adverse Events (AE);Number of Participants With Dose-Limiting Toxicities (DLT);Number of Tumor Lysis Syndrome (TLS);Number of Participants With Clinically Significant Changes From Baseline in Clinical Laboratory Parameters;Number of Participants With Clinically Significant Changes From Baseline in Vital Sign Parameters;Number of Participants With Clinically Significant Changes From Baseline in Electrocardiograms (ECG);Maximum Observed Plasma Concentration (Cmax) of ABBV-525;Time to Cmax (Tmax) of ABBV-525;Area Under the Plasma Concentration-Time Curve (AUC) of ABBV-525

Secondary Outcome Measures

Name	Time	Method
Overall Response Rate (ORR);Duration of Response (DOR)

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