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
NCT ID: NCT06158854
Last Updated: 2025-12-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1/PHASE2
76 participants
INTERVENTIONAL
2024-04-01
2031-09-30
Brief Summary
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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.
Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Dose Escalation: ABBV-383 (etentamig) Dose C
Participants will receive ABBV-383 (etentamig) dose C during the approximately 2 year study duration.
ABBV-383 (Etentamig)
Intravenous Infusion
Dose Expansion: ABBV-383 (etentamig)
Participants will receive ABBV-383 (etentamig) expansion dose B during the approximately 2 year study duration.
ABBV-383 (Etentamig)
Intravenous Infusion
Dose Escalation: ABBV-383 (etentamig) Dose B
Participants will receive ABBV-383 (etentamig) dose B during the approximately 2 year study duration.
ABBV-383 (Etentamig)
Intravenous Infusion
Dose Escalation: ABBV-383 (etentamig) Dose A
Participants will receive ABBV-383 (etentamig) dose A during the approximately 2 year study duration.
ABBV-383 (Etentamig)
Intravenous Infusion
Interventions
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ABBV-383 (Etentamig)
Intravenous Infusion
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 considered risk stage 3b with stable cardiac function and markers for 3 months prior to dosing, and have measurable disease of AL amyloidosis as defined by difference between involved and uninvolved free light chains (dFLC) \>= 50 mg/L or meeting high-risk dFLC progression criteria after immediate prior line of therapy.
* Has previously been exposed to a proteasome inhibitor (PI) and an anti-CD38 monoclonal antibody.
Exclusion Criteria
* Known allergic reaction, significant sensitivity, or intolerance to constituents of the study treatment (and excipients) and/or other products in the same class.
* Participant has the following conditions:
* Other non-AL amyloid disease;
* Previous or current diagnosis of symptomatic multiple myeloma (MM), including the presence of lytic bone disease, plasmacytomas, \>= 60% plasma cells in the bone marrow, or hypercalcemia (defined as corrected calcium \> 11 mg/dL);
* Active plasma cell leukemia (i.e., either 20% of peripheral white blood cells or \> 2.0 × 109/L circulating plasma cells by standard differential);
* Waldenström's macroglobulinemia;
* Acute diffuse infiltrative pneumopathy;
* Major surgery within 28 days prior first dose or planned during study participation;
* History of organ transplant requiring continued use of immunosuppressants;
* Acute infections within 14 days prior first dose requiring parenteral therapy (antibiotic, antifungal, or antiviral);
* Participant has received an autologous stem cell transplant (SCT) within 12 weeks or an allogeneic SCT within 1 year of the first dose of study treatments.
18 Years
ALL
No
Sponsors
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AbbVie
INDUSTRY
Responsible Party
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Principal Investigators
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ABBVIE INC.
Role: STUDY_DIRECTOR
AbbVie
Locations
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Sylvester Comprehensive Cancer Center - University of Miami /ID# 255856
Miami, Florida, United States
Boston Medical Center /ID# 255066
Boston, Massachusetts, United States
Mayo Clinic - Rochester /ID# 255258
Rochester, Minnesota, United States
Icahn School of Medicine at Mount Sinai /ID# 255408
New York, New York, United States
Columbia University Medical Center /ID# 255068
New York, New York, United States
Memorial Sloan Kettering Cancer Center-Koch Center /ID# 255073
New York, New York, United States
Atrium Health Levine Cancer Institute /ID# 255074
Charlotte, North Carolina, United States
Atrium Health Wake Forest Baptist Medical Center /ID# 255851
Winston-Salem, North Carolina, United States
Oregon Medical Research Center /ID# 255119
Portland, Oregon, United States
University of Washington /ID# 261581
Seattle, Washington, United States
Wisconsin Medical Center /ID# 255836
Milwaukee, Wisconsin, United States
Westmead Hospital /ID# 255200
Westmead, New South Wales, Australia
Princess Alexandra Hospital /ID# 255202
Woolloongabba, Queensland, Australia
Box Hill Hospital /ID# 255199
Box Hill, Victoria, Australia
CHU Limoges - Dupuytren 1 /ID# 255370
Limoges, Franche-Comte, France
CHU Toulouse - Hopital Rangueil /ID# 255377
Toulouse, Haute-Garonne, France
Alexandra General Hospital /ID# 255542
Athens, Attica, Greece
IRCCS AOU di Bologna Policlinico Sant Orsola Malpighi /ID# 255654
Bologna, , Italy
Nagoya City University Hospital /ID# 256086
Nagoya, Aichi-ken, Japan
Kumamoto University Hospital /ID# 262579
Kumamoto, Kumamoto, Japan
Japanese Red Cross Medical Center /ID# 256083
Shibuya-ku, Tokyo, Japan
Countries
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Central Contacts
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Facility Contacts
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Site Coordinator
Role: primary
Related Links
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Other Identifiers
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2023-503429-20-00
Identifier Type: OTHER
Identifier Source: secondary_id
M24-209
Identifier Type: -
Identifier Source: org_study_id