ABBV-383 (Etentamig)
DrugIntravenous Infusion
Other names: TNB-383B
NCT Number: NCT06158854
Immunoglobulin light chain (AL) amyloidosis is the most common form of systemic amyloidosis. AL amyloidosis has many root causes and is characterized by the overproduction of AL that are secreted by clonal bone marrow plasma cells. This is a study to determine adverse events and change in disease activity in adult participants with AL amyloidosis treated with ABBV-383.
Etentamig (ABBV-383) is an investigational drug being developed for the treatment of AL amyloidosis. This study in broken into 2 parts (dose escalation and dose expansion) with 4 arms. During dose escalation (arms 1-3) participants will receive 1 of 3 doses of ABBV-383 to determine the part 2 dose. After completion of the dose escalation portion of the study, the dose expansion (part 2) portion of the study will begin. One arm (arm 4) will begin and participants will receive a dose determined during the dose escalation portion (part 1). Around 76 adult participants with relapsed/refractory AL amyloidosis will be enrolled at approximately 25 sites across the world.
Participants will receive Etentamig (ABBV-383) as an infusion into the vein for up to approximately 2 year study duration.
There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and questionnaires.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Phase 1 / Phase 2
Westmead Hospital /ID# 255200, Westmead, New South Wales, Australia
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Intravenous Infusion
Other names: TNB-383B
Time frame: Up to 28 Days
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.
Time frame: Up to 4 years
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).
Time frame: Up to 4 years
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.
Time frame: Up to 4 years
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.
Time frame: Up to 4 Years
Hematologic ORR is defined as partial response (PR) + very good partial response (VGPR) + complete remission (CR), proportion of participants who achieved a PR or better, per the modified IACC.
Time frame: Up to 4 Years
Time to hematologic CR is defined as the time from first dose of study drug until CR, per the modified IACC.
Time frame: Up to 4 Years
Duration of hematologic CR is defined as the time from CR until disease progression, per the modified IACC.
Time frame: Up to 4 Years
Organ response rate is defined as the time from first dose of study drug until to response in the heart kidney and liver, per the IACC.
Time frame: Up to 4 Years
Time to organ response is defined as the time from first dose of study drug until organ response, per the IACC.
Time frame: Up to 4 years
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).
Contact information is provided by the study sponsor or research team.
AbbVie
Industry
An Open-Label Phase 1/2 Study Evaluating the Safety and Efficacy of Etentamig (ABBV-383) in AL Amyloidosis
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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