| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05618028 | Study to Evaluate Adverse Events and Change in Disease Activity in Adult Participants With B-Cell Malignancies Receiving Oral ABBV-525 Tablets | PHASE1 | ACTIVE NOT_RECRUITING | 78 | — | — | Apr 4, 2023 | Jul 1, 2029 | May 4, 2026 | 39 | United States, Australia +8 |
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...