Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06158854 | A Study to Assess Change in Disease Activity and Adverse Events (AE)s in Adult Participants With Immunoglobulin Light Chain (AL) Amyloidosis Receiving Etentamig (ABBV-383) as an Intravenous (IV) Infusion | PHASE1 | RECRUITING | 76 | — | — | Apr 1, 2024 | Aug 1, 2031 | May 13, 2026 | 23 | United States, Australia +4 |
DLT events are defined as clinically significant adverse events or abnormal laboratory values assessed as unrelated to disease progression, underlying disease, intercurrent illness, or concomitant medications.
Hematologic CR is defined as the percentage of participants who achieve normalization of free light chain levels, negative serum immunofixation, negative urine immunofixation as determined per the modified International Amyloidosis Consensus Criteria (IACC).
DLT events are defined as clinically significant adverse events or abnormal laboratory values assessed as unrelated to disease progression, underlying disease, intercurrent illness, or concomitant medications.
An AE is defined as any untoward medical occurrence in a patient or clinical investigation in which a participant is administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment.
| Arm | Type | Description |
|---|---|---|
| Dose Escalation: ABBV-383 (etentamig) Dose A | EXPERIMENTAL | Participants will receive ABBV-383 (etentamig) dose A during the approximately 2 year study duration. |
| Dose Escalation: ABBV-383 (etentamig) Dose B | EXPERIMENTAL | Participants will receive ABBV-383 (etentamig) dose B during the approximately 2 year study duration. |
| Dose Escalation: ABBV-383 (etentamig) Dose C | EXPERIMENTAL | Participants will receive ABBV-383 (etentamig) dose C during the approximately 2 year study duration. |
| Dose Expansion: ABBV-383 (etentamig) | EXPERIMENTAL | Participants will receive ABBV-383 (etentamig) expansion dose B during the approximately 2 year study duration. |
| Name | Type | Description |
|---|---|---|
| ABBV-383 (Etentamig) | DRUG | Intravenous Infusion |
Inclusion Criteria: * Diagnosis of primary systemic immunoglobulin light chain (AL) amyloidosis. * Eastern Cooperative Oncology Group (ECOG) performance status of \<= 2. * Have at least 1 organ historically impacted by AL amyloidosis. * Considered AL amyloidosis cardiac risk stage 1, 2, or 3a, or c...