In short
Surzetoclax is an investigational oral substance being studied in multiple myeloma, a cancer of plasma cells. Two Phase 1 trials, registered under the same identifier NCT06953960, are assessing its safety and tolerability alone and in combination with other antimyeloma agents in adults. The trials involve up to 131 participants.
Key points
- Surzetoclax is an investigational oral substance for multiple myeloma.
- Both trials are Phase 1, focusing on safety and dose determination.
- One trial studies surzetoclax alone or with dexamethasone, daratumumab, or pomalidomide in up to 119 participants.
- The other trial studies surzetoclax with etentamig in up to 131 participants with relapsed or refractory multiple myeloma.
- Both trials are currently Authorised.
- Primary outcomes measure dose-limiting toxicities and overall safety and tolerability.
What is surzetoclax?
Surzetoclax, also known by its development code ABBV-453, is an investigational substance being studied in multiple myeloma. The available trial records do not state its drug class or whether it has any marketing authorisation. It appears in these records as an oral medication.
How does surzetoclax work?
The provided trial records do not describe the mechanism of action of surzetoclax. The studies focus on assessing its safety and tolerability rather than explaining how it works at a molecular level.
Which conditions is surzetoclax studied for?
- Multiple myeloma (MM) — a cancer of plasma cells, a type of white blood cell found in the bone marrow. Both trials enrol adult participants with this condition, including those with relapsed or refractory disease (cancer that has returned or not responded to prior treatment).
How is surzetoclax given?
Surzetoclax is given orally, as indicated in both trial records.
What do the clinical trials show?
Two Phase 1 trials are registered under the same identifier, NCT06953960. Both are currently in the Authorised status, meaning they have been approved to proceed. These are early-stage trials focused on safety and dosing, not yet on demonstrating effectiveness.
What are the trials measuring?
The primary outcomes in both trials are dose-limiting toxicities (DLTs) — side effects severe enough to prevent increasing the dose — and overall safety and tolerability, including adverse events, serious adverse events, laboratory values, vital signs, and electrocardiogram (ECG) results.
Who can take part in these trials?
Both trials enrol adult participants with multiple myeloma. One trial includes participants with relapsed or refractory multiple myeloma who are selected based on specific biomarkers (biological characteristics of their cancer).
What combinations are being studied?
The first trial assesses surzetoclax alone or in combination with dexamethasone, daratumumab, or pomalidomide in up to 119 participants. The second trial assesses surzetoclax in combination with etentamig, an intravenous agent, in up to 131 participants.
What side effects are known?
The provided sources do not list specific side effects for surzetoclax. The trials are designed to identify and characterise side effects, including dose-limiting toxicities, as their primary goal.