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ABBV-525

Phase 1

Diffuse Large B-Cell Lymphoma | Small molecule | Oncology |AbbVie Inc.|Last Updated: May 4, 2026

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedCONTROLLEDDMC
Total Trials1
Total Enrollment78
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT05618028Study to Evaluate Adverse Events and Change in Disease Activity in Adult Participants With B-Cell Malignancies Receiving Oral ABBV-525 TabletsPHASE1 ACTIVE NOT_RECRUITING 78Apr 4, 2023Jul 1, 2029May 4, 202639 United States, Australia +8
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Study Endpoints
Primary Endpoints
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.

Secondary Endpoints
Overall Response Rate (ORR)
Up to Approximately 64 Months
Duration of Response (DOR)
Up to Approximately 64 Months
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
ABBV-525 Dose EscalationEXPERIMENTALParticipants 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 OptimizationEXPERIMENTALParticipants 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 ExpansionEXPERIMENTALParticipants will receive the RP2D dose of ABBV-525, as part of an approximately 64 month study period.
Interventions
NameTypeDescription
ABBV-525DRUGOral; Tablet
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites39

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...

Countries:United StatesAustraliaBelgiumFranceGermanyIsraelSouth KoreaSpainTaiwanUnited Kingdom
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Recent Changes (Last 90 Days)
HIGHMay 26, 2026NCT05618028Status: RECRUITING → ACTIVE_NOT_RECRUITING
LOWMay 24, 2026NCT05618028studyFirstPostDate: changed