Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Surzetoclax · 1 trial · 1 indication
DLT events are defined as specific clinically significant adverse events or abnormal laboratory values assessed as events regardless of attribution to ABBV-453, except those clearly and incontrovertibly associated with underlying disease or extraneous causes.
An adverse event is defined as 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.
| Arm | Type | Description |
|---|---|---|
| Substudy 1: Dose Escalation Surzetoclax Combination | EXPERIMENTAL | Participants will receive various doses of surzetoclax in combination with daratumumab + dexamethasone, to determine the best dose of surzetoclax, as part of the total 4.5 year study duration. |
| Substudy 1: Dose Optimization & Selection ABBV-453 Combination | EXPERIMENTAL | Participants will receive 1 of 2 doses of ABBV-453 in combination with daratumumab + dexamethasone, as part of the total 4.5 year study duration. |
| Substudy 1: Dose Optimization & Selection Control | ACTIVE_COMPARATOR | Participants will receive daratumumab, dexamethasone, and pomalidomide, as part of the total 4.5 year study duration. |
| Substudy 2: Dose Escalation ABBV-453 Monotherapy | EXPERIMENTAL | Japanese participants will receive various doses of ABBV-453 as a monotherapy, to determine the best dose of ABBV-453, as part of the total 4.5 year study duration. |
| Substudy 3: Dose Escalation Surzetoclax + Etentamig | EXPERIMENTAL | Participants will receive various doses of both surzetoclax and etentamig, to determine the best dose of surzetoclax and etentamig, as part of the total 4.5 year study duration. |
| Substudy 3: Dose Optimization Etentamig Dose A Combination | EXPERIMENTAL | Participants will receive etentamig dose A in combination with surzetoclax, as part of the total 4.5 year study duration. |
| Substudy 3: Dose Optimization Etentamig Dose B Combination | EXPERIMENTAL | Participants will receive etentamig dose B in combination with surzetoclax, as part of the total 4.5 year study duration. |
| Substudy 3: Dose Optimization Etentamig Monotherapy | EXPERIMENTAL | Participants will receive etentamig, as part of the total 4.5 year study duration. |
| Name | Type | Description |
|---|---|---|
| Surzetoclax | DRUG | Oral |
| Daratumumab | DRUG | Subcutaneous (SC) Injection |
| Dexamethasone | DRUG | Oral |
| Pomalidomide | DRUG | Oral |
| Etentamig | DRUG | Intravenous Infusion |
Inclusion Criteria: * Documented diagnosis of multiple myeloma (MM) based on standard international myeloma working group (IMWG) diagnostic criteria. * All participants must have measurable disease per central laboratory with at least 1 of the following assessed within 28 days prior to enrollment: ...
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Surzetoclax is an investigational small molecule being studied for the treatment of multiple myeloma. It is currently in Phase 1 clinical development and is not yet approved by regulatory authorities. The drug is being evaluated alone and in combination with other antimyeloma agents in adult participants with multiple myeloma.
Surzetoclax is being developed by AbbVie Inc., a biopharmaceutical company traded on the New York Stock Exchange under the ticker ABBV. The company is conducting a Phase 1 clinical trial to assess the safety and efficacy of the drug in patients with multiple myeloma.
Surzetoclax is currently in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by the FDA or other regulatory agencies. The ongoing Phase 1 trial is actively recruiting participants to evaluate the drug's safety and disease activity in multiple myeloma.
Surzetoclax is being studied in one active Phase 1 clinical trial with the identifier NCT06953960. This trial is recruiting 325 adult participants with multiple myeloma across multiple countries, including the United States, Australia, Belgium, France, Germany, Israel, Italy, Japan, Poland, Portugal, Sweden, and the United Kingdom.
Surzetoclax is being tested both alone and in combination with subcutaneous and/or oral antimyeloma agents. The Phase 1 trial is designed to assess adverse events and changes in disease activity when the drug is administered as a monotherapy or as part of a combination regimen in adults with multiple myeloma.
Yes, the Phase 1 clinical trial of Surzetoclax is randomized and active-controlled, meaning participants are assigned to different treatment groups to compare the investigational drug against an active control. The trial is not double-blinded and does not require a biomarker-selected patient population.