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NCT Number: NCT06158854

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

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Westmead Hospital /ID# 255200, Westmead, New South Wales, Australia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 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 history of clinically significant (per investigator's judgment) drug or alcohol abuse within the last 6 months.
  • 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.

Treatment and study plan

ABBV-383 (Etentamig)

Drug

Intravenous Infusion

Other names: TNB-383B

Primary outcomes

  1. Dose Escalation Only: Number of Participants with Dose-Limiting Toxicities (DLT)

    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.

  2. Dose Expansion Only: Percentage of Participants who Achieve Hematologic Complete Response (CR)

    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).

  3. Dose Expansion Only: Number of Participants with DLTs

    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.

  4. Number of Participants with Adverse Events (AEs)

    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.

Secondary outcomes

  1. Hematologic Overall Response Rate (ORR)

    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.

  2. Time to Hematologic CR

    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.

  3. Duration of Hematologic CR

    Time frame: Up to 4 Years

    Duration of hematologic CR is defined as the time from CR until disease progression, per the modified IACC.

  4. Organ Response Rate (OrRR)

    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.

  5. Time to Organ Response

    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.

  6. Dose Escalation Only: Percentage of Participants who Achieve Hematologic CR Rate as Determined

    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).

Study contacts

Contact information is provided by the study sponsor or research team.

ABBVIE CALL CENTER

CONTACT

[email protected]

844-663-3742

Sponsors and collaborators

Lead sponsor

AbbVie

Industry

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2028
Study completion
2031
First posted
Dec 6, 2023
Registry last updated
May 13, 2026

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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