A Study to Assess the Adverse Events and Change in Disease Activity in Adult Participants With Relapsed or Refractory Multiple Myeloma Receiving Oral ABBV-453 Tablets

Overview

Multiple myeloma (MM) is a plasma cell disease characterized by the growth of clonal plasma cells in the bone marrow. The purpose of this study is to assess the safety and toxicity of ABBV-453 in adult participants with relapsed/refractory (R/R) MM. Adverse events and change in disease activity will be assessed. ABBV-453 is an investigational drug being developed for the treatment of R/R MM. This study will include a dose escalation phase to determine the best dose of ABBV-453. Approximately 21 adult participants with R/R MM will be enrolled in the study in approximately 12 sites worldwide. Participants will receive oral ABBV-453 tablets once daily (QD) in 28-day cycles. 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 an approved institution (hospital or clinic). The effect of the treatment will be frequently checked by medical assessments, blood tests, and side effects.

Full Title of Study: “First-in-Human Study of the BCL-2 Inhibitor ABBV-453 in Biomarker-Selected Subjects With Relapsed or Refractory Multiple Myeloma”

Study Type

• Study Type: Interventional
• Study Design
  • Allocation: N/A
  • Intervention Model: Single Group Assignment
  • Primary Purpose: Treatment
  • Masking: None (Open Label)
• Study Primary Completion Date: April 27, 2026

Interventions

• Drug: ABBV-453
  • Oral; Tablet

Arms, Groups and Cohorts

• Experimental: Dose Escalation ABBV-453
  • Participants with relapsed or refractory (R/R) multiple myeloma (MM) will receive escalating doses of ABBV-453, until the maximum tolerated dose (MTD) is determined.

Clinical Trial Outcome Measures

Primary Measures

• Overall Response Rate (ORR) per Adapted International Myeloma Working Group (IMWG) criteria
  • Time Frame: Up to Approximately 12 Months
  • ORR is defined as the percentage of participants with a confirmed best overall response (BOR) of partial response (PR) + very good partial response (VGPR) + complete response (CR) + stringent complete response (sCR) as assessed by investigators per adapted IMWG criteria for relapsed or refractory (R/R) multiple myeloma (MM).

Secondary Measures

• Duration of Response (DOR)
  • Time Frame: Up to Approximately 24 Months
  • DOR is defined for participants achieving a confirmed sCR/CR/VGPR/PR as the time from the initial response of sCR/CR/VGPR/PR per investigator review according to adapted IMWG criteria to disease progression or death of any cause, whichever occurs earlier.
• Depth of Response Minimal Residual Disease (MRD)
  • Time Frame: Up to Approximately 24 Months
  • MRD negativity is defined as having less than 1 myeloma cell that may remain in the bone marrow aspirate. Depth of response is defined as the proportion of MRD negativity for participants achieving a confirmed sCR/CR per investigator review according to adapted IMWG criteria.
• Progression Free Survival (PFS)
  • Time Frame: Up to Approximately 36 Months
  • PFS is defined as time from first study treatment to a documented disease progression according to adapted IMWG criteria, as determined by the investigator, or death due to any cause, whichever occurs earlier.
• Overall Survival (OS)
  • Time Frame: Up to Approximately 36 Months
  • Overall survival (OS) is defined as time from first study treatment to death due to any cause.

Participating in This Clinical Trial

Inclusion Criteria

• Eastern Cooperative Oncology Group (ECOG) performance status <= 1. – Laboratory values meeting the criteria outlined in the protocol. – Documented diagnosis of multiple myeloma (MM) based on standard International Myeloma Working Group (IMWG) criteria. – Has measurable disease at screening as defined in the protocol. – Known or centrally determined t(11;14) positive status and/or centrally determined BCL2high status. – Refractory to or intolerant of all established MM therapies that are known to provide clinical benefit and received all standard of care (SOC) agents in previous line(s) of therapy, including a proteasome inhibitors (PI), an Immunomodulatory drugs (IMID), and an anti-CD38 monoclonal antibody. – Permitted to be venetoclax or BCL-2 inhibitor exposed in previous lines of therapy. – Life expectancy >= 12 weeks. Exclusion Criteria:

• Clinically relevant or significant Electrocardiogram (ECG) abnormalities as outlined in the protocol.

Gender Eligibility: All

Minimum Age: 19 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

• Lead Sponsor
  • AbbVie
• Provider of Information About this Clinical Study
  • Sponsor
• Overall Official(s)
  • ABBVIE INC., Study Director, AbbVie
• Overall Contact(s)
  • ABBVIE CALL CENTER, 844-663-3742, abbvieclinicaltrials@abbvie.com