An Open-Label Phase 1b Study Evaluating the Safety and Efficacy of Etentamig (ABBV-383) in AL Amyloidosis

Status: Recruiting
Location: See all (20) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1/Phase 2
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 safety expansion) with 5 arms. During dose escalation (arms 1-3) participants will receive 1 of 3 doses of ABBV-383 to determine the part 2 doses. After completion of the dose escalation portion of the study, the safety expansion (part 2) portion of the study will begin. Two arms (arm 4-5) will begin and participants will receive 1 of 2 doses as determined during the dose escalation portion (part 1). Around 76 adult participants with relapsed/refractory AL amyloidosis will be enrolled at approximately 20 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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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 risk stage 1, 2, or 3a and have measurable disease of AL amyloidosis as defined by difference between involved and uninvolved free light chains (dFLC) \>= 50 mg/L.

• Has previously been exposed to a proteasome inhibitor (PI) and an anti-CD38 monoclonal antibody.

Locations
United States
Florida
Sylvester Comprehensive Cancer Center - University of Miami /ID# 255856
RECRUITING
Miami
Massachusetts
Boston Medical Center /ID# 255066
RECRUITING
Boston
Minnesota
Mayo Clinic - Rochester /ID# 255258
RECRUITING
Rochester
North Carolina
Levine Cancer Institute /ID# 255074
RECRUITING
Charlotte
Wake Forest Baptist Health /ID# 255851
RECRUITING
Winston-salem
New York
Columbia University Medical Center /ID# 255068
RECRUITING
New York
Memorial Sloan Kettering Cancer Center-Koch Center /ID# 255073
RECRUITING
New York
Oregon
Oregon Medical Research Center /ID# 255119
RECRUITING
Portland
Washington
University of Washington /ID# 261581
RECRUITING
Seattle
Wisconsin
Wisconsin Medical Center /ID# 255836
RECRUITING
Milwaukee
Other Locations
Australia
Box Hill Hospital /ID# 255199
RECRUITING
Box Hill
Westmead Hospital /ID# 255200
RECRUITING
Westmead
Princess Alexandra Hospital /ID# 255202
RECRUITING
Woolloongabba
France
CHU Limoges - Dupuytren 1 /ID# 255370
RECRUITING
Limoges
CHU Toulouse - Hopital Rangueil /ID# 255377
RECRUITING
Toulouse
Greece
Alexandra General Hospital /ID# 255542
RECRUITING
Athens
Italy
IRCCS AOU di Bologna Policlinico Sant Orsola Malpighi /ID# 255654
RECRUITING
Bologna
Japan
Kumamoto University Hospital /ID# 262579
RECRUITING
Kumamoto
Nagoya City University Hospital /ID# 256086
RECRUITING
Nagoya
Japanese Red Cross Medical Center /ID# 256083
RECRUITING
Shibuya-ku
Contact Information
Primary
ABBVIE CALL CENTER
abbvieclinicaltrials@abbvie.com
844-663-3742
Time Frame
Start Date: 2024-04-01
Estimated Completion Date: 2028-02
Participants
Target number of participants: 76
Treatments
Experimental: Dose Escalation: ABBV-383 (etentamig) Dose A
Participants will receive ABBV-383 (etentamig) dose A during the approximately 2 year study duration.
Experimental: Dose Escalation: ABBV-383 (etentamig) Dose B
Participants will receive ABBV-383 (etentamig) dose B during the approximately 2 year study duration.
Experimental: Dose Escalation: ABBV-383 (etentamig) Dose C
Participants will receive ABBV-383 (etentamig) dose C during the approximately 2 year study duration.
Experimental: Safety Expansion: ABBV-383 (etentamig) Expansion A
Participants will receive ABBV-383 (etentamig) expansion dose A during the approximately 2 year study duration.
Experimental: Safety Expansion: ABBV-383 (etentamig) Expansion B
Participants will receive ABBV-383 (etentamig) expansion dose B during the approximately 2 year study duration.
Related Therapeutic Areas
Sponsors
Leads: AbbVie

This content was sourced from clinicaltrials.gov