[M23-001] A Multicenter, Phase 1b, Open-label Study of ABBV-383 Administered Subcutaneously in Subjects With Relapsed or Refractory Multiple Myeloma

JRCT ID: jRCT2041240056

Registered date:17/07/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Multiple Myeloma
• Date of first enrollment: 26/09/2024
• Target sample size: 3
• Countries of recruitment: Germany,Japan,Israel,Japan
• Study type: Interventional

Intervention(s)

Experimental: ABBV-383 Dose A
Participants will receive Dose A of ABBV-383 as a subcutaneous (SC) injection and intravenous (IV) infusions, during the 151 week study duration.

Experimental: ABBV-383 Dose B
Participants will receive Dose B of ABBV-383 as an SC injection and IV infusions, during the 151 week study duration.

Experimental: ABBV-383 Expansion
Participants will receive the selected dose from Arm A of ABBV-383 as SC injections, during the 151 week study duration.

Outcome(s)

Primary Outcome

Percentage of Participants Experiencing Cytokine Release Syndrome (CRS) Events
Percentage of Participants Experiencing Immune Cell-Associated Neurotoxicity Syndrome (ICANS) Events
Maximum Observed Concentration (Cmax) of ABBV-383
Time to Cmax (Tmax) of ABBV-383
Trough Concentration (Ctrough) of ABBV-383
Area Under the Plasma Concentration-time Curve (AUC) of ABBV-383

Secondary Outcome

Overall Response Rate (ORR)
Percentage of Participants Achieving Stringent Complete Response (sCR)
Percentage of Participants Achieving Complete Response (CR)
Percentage of Participants Achieving Very Good Partial Response (VGPR)
Percentage of Participants Achieving Partial Response (PR)
Duration of Response (DoR)
Progression Free Survival (PFS)
Time to Response (TTR)
Immunogenicity of ABBV-383 as Determined by Anti-Drug Antibodies (ADAs)
Immunogenicity of ABBV-383 as Determined by Neutralizing Anti-Drug Antibodies (NAbs)

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable

Include criteria

Eastern Cooperative Oncology Group (ECOG) performance of <= 2.
Participants with relapsed or refractory multiple myeloma who have received 3-5 prior lines of therapies and with prior triple class exposure including a proteasome inhibitor, anti-CD38 monoclonal antibody and an immunomodulatory drug.
Must be naive to treatment with ABBV-383.

• Exclude criteria: Received B-cell maturation antigen (BCMA)xCD3 bispecific antibody.

Related Information

• Primary Sponsor: Satomi Natsuko
• Secondary ID(s): NCT06223516