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RECRUITING
NCT06158854
PHASE1/PHASE2

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

Sponsor: AbbVie

View on ClinicalTrials.gov

Summary

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.

Official title: An Open-Label Phase 1/2 Study Evaluating the Safety and Efficacy of Etentamig (ABBV-383) in AL Amyloidosis

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

76

Start Date

2024-04-01

Completion Date

2031-09

Last Updated

2025-12-17

Healthy Volunteers

No

Interventions

DRUG

ABBV-383 (Etentamig)

Intravenous Infusion

Locations (21)

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