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

Condition(s) studied

Investigational drug(s) / intervention(s)

ABBV-525: Oral; Tablet

Study 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.

Eligibility

Primary outcome measure(s)

• Number of Participants With Adverse Events (AE) — Up to Approximately 64 Months
  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.
• Number of Participants With Dose-Limiting Toxicities (DLT) — Up to Approximately 28 Days
  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).
• Number of Tumor Lysis Syndrome (TLS) — Up to Approximately 64 Months
  TLS is confirmed by evaluation of electrolyte and fluid status and renal status including urine output.
• Number of Participants With Clinically Significant Changes From Baseline in Clinical Laboratory Parameters — Up to Approximately 64 Months
  Clinical laboratory parameters included tests of hematology, chemistry, urinalysis and prolactin. The investigator will assess the results for clinical significance.
• Number of Participants With Clinically Significant Changes From Baseline in Vital Sign Parameters — Up to Approximately 64 Months
  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.
• Number of Participants With Clinically Significant Changes From Baseline in Electrocardiograms (ECG) — Up to Approximately 64 Months
  A standard 12-lead ECG will be performed. The investigator will assess the results for clinical significance.
• Maximum Observed Plasma Concentration (Cmax) of ABBV-525 — Up to 12 Months
  Maximum observed plasma concentration of ABBV-525.
• Time to Cmax (Tmax) of ABBV-525 — Up to 12 Months
  Time to Cmax of ABBV-525.
• Area Under the Plasma Concentration-Time Curve (AUC) of ABBV-525 — Up to 12 Months
  Area under the plasma concentration-time curve of ABBV-525.

Trial sites (39)