Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
ABBV-453 · 2 trials · 2 indications
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.
ORR is defined as the percentage of participants with a confirmed best overall response (BOR) of partial response (PR) + very good partial response (VGPR) + complete response (CR) + stringent complete response (sCR) as assessed by investigators per adapted IMWG criteria for relapsed or refractory (R/R) multiple myeloma (MM).
| 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. |
| Part 1: Monotherapy Dose Escalation | EXPERIMENTAL | Participants with relapsed or refractory (R/R) multiple myeloma (MM) will receive escalating doses of ABBV-453, until the maximum tolerated dose (MTD) is determined. |
| Part 2: Arm 1 | EXPERIMENTAL | Participants will receive continuous doses of ABBV-453 in combination with dexamethasone in 28-day cycles. |
| Part 2: Arm 2 | EXPERIMENTAL | Participants will receive continuous doses of ABBV-453 in combination with daratumumab and dexamethasone in 28-day cycles. |
| Part 2: Arm 3 | EXPERIMENTAL | Participants will receive continuous doses of ABBV-453 in combination with daratumumab, lenalidomide, and dexamethasone in 28-day cycles. |
| Japan Cohort | EXPERIMENTAL | Participants with R/R MM will receive escalating doses of ABBV-453, until the MTD is determined. |
| Name | Type | Description |
|---|---|---|
| Surzetoclax | DRUG | Oral |
| Daratumumab | DRUG | Subcutaneous (SC) Injection |
| Dexamethasone | DRUG | Oral |
| Pomalidomide | DRUG | Oral |
| Etentamig | DRUG | Intravenous Infusion |
| ABBV-453 | DRUG | Oral; Tablet |
| Lenalidomide | DRUG | Oral Capsule |
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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ABBV-453 is an investigational oral small molecule being studied for the treatment of multiple myeloma, including relapsed or refractory multiple myeloma. It is currently in Phase 1 clinical development and has not been approved by regulatory authorities.
ABBV-453 is being developed by AbbVie Inc., a biopharmaceutical company traded on the New York Stock Exchange under the ticker ABBV.
ABBV-453 is in Phase 1 clinical development. It is an investigational drug and has not been approved for any use. Clinical trials are ongoing to assess its safety and efficacy in patients with multiple myeloma.
ABBV-453 is being evaluated in two Phase 1 trials. NCT05308654 is an active, not recruiting study in relapsed or refractory multiple myeloma. NCT06953960 is a recruiting study of surzetoclax, also known as ABBV-453, alone or in combination with other antimyeloma agents in multiple myeloma.
Yes, ABBV-453 is also known as surzetoclax. Clinical trial NCT06953960 refers to the drug as surzetoclax, while NCT05308654 uses the name ABBV-453. Both trials are sponsored by AbbVie and study the same investigational agent.