A Study to Assess Adverse Events of Intravenously (IV) Infused ABBV-383 in Adult Participants With Relapsed or Refractory Multiple Myeloma

• ClinicalTrials.gov Identifier: NCT05650632
• Recruitment Status: Recruiting
• First Posted: December 14, 2022
• Last Update Posted: February 6, 2024
• Sponsor: TeneoOne Inc.
• Information provided by (Responsible Party): TeneoOne Inc.

Tracking Information

• First Submitted Date: December 6, 2022
• First Posted Date: December 14, 2022
• Last Update Posted Date: February 6, 2024
• Actual Study Start Date: March 21, 2023
• Estimated Primary Completion Date: July 12, 2026 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: November 9, 2023)

• Arm A (Part 1 and Part 2): Number of Grade >= 2 Cytokine Release Syndrome (CRS) Events [ Time Frame: Up to Day 28 ]
  CRS is defined by fever, hypoxia, and hypotension and graded according to the American Society for Transplantation and Cellular Therapy (ASTCT) guidelines
• Arm B: Number of Adverse Events (AEs) of Special Interest (CRS and Immune Effector Cell-associated Neurotoxicity Syndrome [ICANS]) [ Time Frame: Up to Day 28 ]
  AEs of special interest will be graded according to American Society for Transplantation and Cellular Therapy (ASTCT) 2019 guidelines. All other AEs will be graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0.

Original Primary Outcome Measures (submitted: December 6, 2022)

Number of Grade >= 2 Cytokine Release Syndrome (CRS) Events [ Time Frame: Up to Day 28 ]

CRS is defined by fever, hypoxia, and hypotension and graded according to the American Society for Transplantation and Cellular Therapy (ASTCT) guidelines

Current Secondary Outcome Measures (submitted: November 9, 2023)

Arm A: Number of Cytokine Release Syndrome (CRS) Events [ Time Frame: Up to 3 Years ]

CRS is defined by fever, hypoxia, and hypotension and graded according to the American Society for Transplantation and Cellular Therapy (ASTCT) guidelines

Original Secondary Outcome Measures (submitted: December 6, 2022)

Number of Cytokine Release Syndrome (CRS) Events [ Time Frame: Up to 3 Years ]

CRS is defined by fever, hypoxia, and hypotension and graded according to the American Society for Transplantation and Cellular Therapy (ASTCT) guidelines

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: A Study to Assess Adverse Events of Intravenously (IV) Infused ABBV-383 in Adult Participants With Relapsed or Refractory Multiple Myeloma
• Official Title: A Multicenter, Phase 1b, Open-label Study to Evaluate Dose Optimization Measures and Safety of ABBV-383 in Subjects With Relapsed or Refractory Multiple Myeloma

Brief Summary

Multiple Myeloma (MM) is a cancer of the blood's plasma cells ( blood cell). The cancer is typically found in the bones and bone marrow (the spongy tissue inside of the bones) and can cause bone pain, fractures, infections, weaker bones, and kidney failure. Treatments are available, but MM can come back (relapsed) or may not get better (refractory) with treatment. This is a study to determine adverse events and change in disease symptoms of ABBV-383 in adult participants with relapsed/refractory (R/R) MM.

ABBV-383 is an investigational drug being developed for the treatment of R/R Multiple Myeloma (MM). This study is broken into 2 Arms; Arm A (Parts 1 and 2) and Arm B. Arm A includes 2 parts: step-up dose optimization (Part 1) and dose expansion (Part 2). In Part 1, different level of step-up doses are tested followed by the target dose of ABBV-383. In Part 2, the step-up dose identified in Part 1 (Dose A) will be used followed by the target dose A of ABBV-383. In Arm B a flat dose of ABBV-383 will be tested. Around 120 adult participants with relapsed/refractory multiple myeloma will be enrolled at approximately 30 sites across the world.

Participants will receive ABBV-383 as an infusion into the vein in 28 day cycles for approximately 3 years.

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.

• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 1
• Study Design: Allocation: Non-Randomized; Intervention Model: Sequential Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Multiple Myeloma

Intervention

Drug: ABBV-383

Intravenous Infusion

Study Arms

• Experimental: Arm A (Part 1): ABBV-383 Dose Escalation
  B-cell maturation antigen (BCMA) naïve participants will receive different doses of ABBV-383 in 28 day cycles.
  Intervention: Drug: ABBV-383
• Experimental: Arm A (Part 2): ABBV-383 Dose Expansion
  BCMA naïve participants will receive the dose of ABBV-383 dose A in 28 day cycles.
  Intervention: Drug: ABBV-383
• Experimental: Arm B: ABBV-383 Dose Expansion
  Participants previously exposed to BCMA-targeted agents will receive ABBV-383 Dose A in 28 day cycles.
  Intervention: Drug: ABBV-383

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: November 9, 2023): 120
• Original Estimated Enrollment (submitted: December 6, 2022): 80
• Estimated Study Completion Date: July 12, 2026
• Estimated Primary Completion Date: July 12, 2026 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• Must have measurable disease as outlined in the protocol.
• Eastern Cooperative Oncology Group (ECOG) performance of <= 2.
• Relapsed/refractory (R/R) multiple myeloma (MM) with documented evidence of progression during or after the participant's last treatment regimen based on the investigator's determination of the International Myeloma Working Group (IMWG) 2016 criteria.
• Must be naïve to treatment with ABBV-383.
• Arm A: Must have received at least 3 or more lines of therapy, including a proteasome inhibitor (PI), an immunomodulatory imide drug (IMiD), and an anti-CD38 monoclonal antibody.
• Arm B: Must have received at least 2 or more lines of therapy, including exposure to a PI, an IMiD, an anti-CD38 monoclonal antibody, and a prior B-cell maturation antigen (BCMA)-targeted therapy (anti-drug conjugate [ADC] or chimeric antigen receptor T-cell [CAR-T] directed against BCMA).

Exclusion Criteria:

- Arm A: Received BCMA-targeted therapy.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: ABBVIE CALL CENTER; 844-663-3742; abbvieclinicaltrials@abbvie.com

• Listed Location Countries: Canada, Denmark, France, Israel, Spain, United Kingdom, United States

Administrative Information

• NCT Number: NCT05650632
• Other Study ID Numbers: M24-108; 2023-504674-38-00 ( Other Identifier: EU CT )
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: TeneoOne Inc.
• Original Responsible Party: Same as current
• Current Study Sponsor: TeneoOne Inc.
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Director: TeneoOne Inc; TeneoOne Inc.

• PRS Account: TeneoOne Inc.
• Verification Date: February 2024