A Study of the Safety and Tolerability of ABBV-467 in Adult Participants With Relapsed/Refractory (R/R) Multiple Myeloma

• Status: Terminated
• Trial end date: 2021-04-16
• Target enrollment: 0
• Participant gender: All

Summary

This first-in-human study will evaluate the safety and tolerability of ABBV-467 in adult participants with relapsed/refractory multiple myeloma (MM).

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AbbVie

Criteria

Inclusion Criteria:

• Documented diagnosis of multiple myeloma (MM).

• Measurable disease defined as at least 1 of the following:

• Serum monoclonal protein >= 1g/dL.

• Urine M-protein >= 200mg/24 hours.

• Serum immunoglobulin free light chain (FLC) >= 10 mg/dL (100 mg/L), provided serum FLC ratio is abnormal.

• Relapsed after or are refractory or intolerant to all established MM therapies that are both known to provide clinical benefit and locally available.

• Received at least 3 prior lines of therapy including 1 or more immunomodulatory agents, 1 or more proteasome inhibitors, and 1 or more anti-CD38 monoclonal antibodies.

• Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.

• Adequate hematologic, renal and hepatic function as described in the protocol.

• Echocardiogram with ejection fraction >= 50% and no other clinically significant findings that would increase the participant's susceptibility to cardiac toxicity.

Exclusion Criteria:

• Prior exposure to any targeted myeloid cell leukemia-1 (MCL-1) inhibitor.

• Antineoplastic therapy (including any cytotoxic, targeted and/or investigational therapy; but not including corticosteroids), within 28 days or 5 half-lives, whichever is shorter, prior to the first dose of study drug and through the last dose of study drug.

• Autologous stem cell transplant within 90 days prior to start of study drug.

• Allogenic stem cell transplant within 180 days prior to start of study drug.

• History of acute or chronic pancreatitis.

• Significant unresolved liver disease.

• History of hepatitis B or human immunodeficiency virus (HIV) infection.