Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
ABBV-453 · 2 trials · 3 indications
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above.
MAD is defined as the highest administered dose if no maximum tolerated dose (MTD) is determined.
MTD is defined as the highest dose administered that does not result in a final determination of de-escalate at that dose level.
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 |
|---|---|---|
| Part A: Cohort 1.1 ABBV-453 Dose A | EXPERIMENTAL | Participants will receive obinutuzumab during the debulking period followed escalating doses of ABBV-453, until the dose A is achieved, during the 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 |
|---|---|---|
| Obinutuzumab | DRUG | Intravenous Infusion |
| ABBV-453 | DRUG | Oral; Tablet |
| Dexamethasone | DRUG | Oral Tablet |
| Daratumumab | DRUG | Subcutaneous Injection |
| Lenalidomide | DRUG | Oral Capsule |
Inclusion Criteria: * Relapsed/refractory (R/R) chronic lymphocytic leukemia (CLL)/ small lymphocytic lymphoma (SLL) that has received at least 2 prior systemic therapies and have no available (or established) therapies known to provide clinical benefit and to which the participant would consent to...
ABBV-453 is an investigational oral small molecule being studied in adults with relapsed or refractory blood cancers, specifically chronic lymphocytic leukemia (CLL), small lymphocytic lymphoma (SLL), and relapsed or refractory multiple myeloma. It is not approved for any indication and remains in Phase 1 clinical development.
ABBV-453 is being developed by AbbVie Inc., which trades on the New York Stock Exchange under the ticker ABBV. AbbVie is the sponsor of the Phase 1 studies evaluating the drug in relapsed or refractory chronic lymphocytic leukemia, small lymphocytic lymphoma, and multiple myeloma.
ABBV-453 is in Phase 1 clinical development. Both listed studies are Phase 1 trials, and neither has been completed. The drug is investigational and has not received FDA approval for any indication.
ABBV-453 is being evaluated in two Phase 1 trials. NCT06291220 is assessing adverse events and how oral ABBV-453 moves through the body in adults with relapsed or refractory CLL/SLL, with 4 participants enrolled across the United States, Australia, Germany, Israel, and Italy. NCT05308654 is studying adverse events and disease activity changes in 34 adults with relapsed or refractory multiple myeloma across the United States, Australia, Israel, and the United Kingdom. Both trials are active but not recruiting.
No. ABBV-453 is an investigational drug in Phase 1 clinical development and has not been approved by the FDA for any indication. It is being studied in adults with relapsed or refractory chronic lymphocytic leukemia, small lymphocytic lymphoma, and multiple myeloma.
ABBV-453 is an oral small molecule. The Phase 1 trial NCT05308654 describes administration as oral ABBV-453 tablets in adults with relapsed or refractory multiple myeloma, and NCT06291220 also evaluates oral ABBV-453 in adults with relapsed or refractory CLL/SLL.