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

Status
Not yet recruiting
Phases
Phase 1Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2025-525105-20-00
Enrollment
76
Registered
2026-07-13
Start date
Unknown
Completion date
Unknown
Last updated
2026-07-14

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) of surzetoclax and etentamig in combination in biomarker-selected subjects with R/R MM.

Detailed description

Overall Response Rate (ORR), Progression-Free Survival (PFS), Duration of Response (DOR), Time-to-Progression (TTP), Time to Next Treatment, Rate of minimal residual disease (MRD) Negativity Determined Centrally, using Adaptive's clonoSEQ NGS assay, Overall survival (OS), Pharmacokinetics (PK): Cmax, Tmax, t ½ , AUC.

Interventions

Sponsors

AbbVie Deutschland GmbH & Co. KG
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Dose Limiting Toxicities (DLT) of surzetoclax and etentamig in combination in biomarker-selected subjects with R/R MM.

Secondary

MeasureTime frame
Overall Response Rate (ORR), Progression-Free Survival (PFS), Duration of Response (DOR), Time-to-Progression (TTP), Time to Next Treatment, Rate of minimal residual disease (MRD) Negativity Determined Centrally, using Adaptive's clonoSEQ NGS assay, Overall survival (OS), Pharmacokinetics (PK): Cmax, Tmax, t ½ , AUC.

Outcome results

None listed

Source: EU CTIS · Data processed: Jul 15, 2026