A Phase 1/2, Open-Label, Platform Study to Evaluate Safety and Efficacy of the BCL-2 Inhibitor ABBV-453 given as Monotherapy or in Combination with Antimyeloma Regimens in Subjects with Multiple Myeloma

Status

Recruiting

Phases

Phase 1Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-517140-65-00

Acronym

M25-275

Enrollment

Registered

2025-10-06

Start date

2025-10-23

Completion date

Unknown

Last updated

2025-12-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multiple Myeloma (MM).

Brief summary

Dose Limiting Toxicities (DLT)s of ABBV-453, Safety and tolerability (AEs and SAEs, clinical laboratory parameters, vital sign measurements, and ECG results).

Detailed description

Overall Response Rate (ORR), Progression-Free Survival (PFS), Duration of Response (DOR), Time-to-Progression (TTP), Time to Next Treatment, Rate and Depth of minimal residual disease (MRD) Negativity Determined Centrally, Overall survival (OS), Pharmacokinetics (PK): Cmax, Tmax, t ½ , AUC.

Interventions

DRUGDARATUMUMAB

DRUGDEXAMETHASONE

DRUGPOMALIDOMIDE

DRUGSurzetoclax

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Dose Limiting Toxicities (DLT)s of ABBV-453, Safety and tolerability (AEs and SAEs, clinical laboratory parameters, vital sign measurements, and ECG results).	—

Secondary

Measure	Time frame
Overall Response Rate (ORR), Progression-Free Survival (PFS), Duration of Response (DOR), Time-to-Progression (TTP), Time to Next Treatment, Rate and Depth of minimal residual disease (MRD) Negativity Determined Centrally, Overall survival (OS), Pharmacokinetics (PK): Cmax, Tmax, t ½ , AUC.	—

Countries

Belgium, France, Germany, Italy, Poland, Portugal, Sweden

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026