Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as ABBV-383 (Etentamig)
ABBV-383 · 1 trial · 1 indication
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...
ABBV-383, also known as Etentamig, is an investigational small molecule being developed for the treatment of Immunoglobulin Light Chain (AL) Amyloidosis, a rare disease. It is administered as an intravenous infusion and is currently in Phase 1 clinical development.
ABBV-383 is a small molecule being studied for its effects on disease activity in adult participants with Immunoglobulin Light Chain (AL) Amyloidosis. Its specific molecular target has not been disclosed in the available clinical trial information.
ABBV-383 is being developed by AbbVie Inc., a biopharmaceutical company traded on the New York Stock Exchange under the ticker ABBV. The drug is currently in Phase 1 clinical trials for Immunoglobulin Light Chain (AL) Amyloidosis.
ABBV-383 is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. A Phase 1 study is currently recruiting participants to assess change in disease activity and adverse events in adults with AL amyloidosis.
ABBV-383 is being evaluated in a Phase 1 clinical trial with the identifier NCT06158854. This study is recruiting 76 adult participants with Immunoglobulin Light Chain (AL) Amyloidosis across the United States, Australia, France, Greece, Italy, and Japan, and is assessing disease activity and adverse events.
Yes, ABBV-383 is also known as Etentamig. The drug is being studied under both names in clinical research, and the Phase 1 trial NCT06158854 refers to it as Etentamig (ABBV-383) for the treatment of AL amyloidosis.