Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
ABBV-525 · 1 trial · 4 indications
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.
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).
TLS is confirmed by evaluation of electrolyte and fluid status and renal status including urine output.
Clinical laboratory parameters included tests of hematology, chemistry, urinalysis and prolactin. The investigator will assess the results for clinical significance.
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.
A standard 12-lead ECG will be performed. The investigator will assess the results for clinical significance.
Maximum observed plasma concentration of ABBV-525.
Time to Cmax of ABBV-525.
Area under the plasma concentration-time curve of ABBV-525.
| Arm | Type | Description |
|---|---|---|
| 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. |
| 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. |
| ABBV-525 Dose Expansion | EXPERIMENTAL | Participants will receive the RP2D dose of ABBV-525, as part of an approximately 64 month study period. |
| Name | Type | Description |
|---|---|---|
| ABBV-525 | DRUG | Oral; Tablet |
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...
ABBV-525 is an investigational oral small molecule being studied for the treatment of B-cell malignancies, including Diffuse Large B-Cell Lymphoma, Chronic Lymphocytic Leukemia, and Non-Hodgkin's Lymphoma. It is currently in Phase 1 clinical development and is not yet approved by regulatory authorities.
ABBV-525 is being developed by AbbVie Inc., a biopharmaceutical company traded on the New York Stock Exchange under the ticker ABBV. The company is conducting a Phase 1 clinical trial to evaluate the drug in adult participants with B-cell malignancies.
ABBV-525 is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by the FDA or other regulatory agencies. The ongoing Phase 1 trial is active but not recruiting participants, with a planned enrollment of 78 adults.
ABBV-525 is being evaluated in a Phase 1 clinical trial registered as NCT05618028. The study is assessing adverse events and change in disease activity in adult participants with B-cell malignancies receiving oral ABBV-525 tablets. The trial is active but not recruiting and includes sites in the United States, Australia, Belgium, France, Germany, Israel, South Korea, Spain, Taiwan, and the United Kingdom.
ABBV-525 is a small molecule drug, but its specific molecular target has not been disclosed in the available information. The ongoing Phase 1 trial is evaluating its safety and disease activity in B-cell malignancies, including Diffuse Large B-Cell Lymphoma, without biomarker-based patient selection.