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Closed (no longer recruiting)Last updated: 9 January 2024

M19-025: This phase I trial will begin to understand how safe and tolerable an intravenous cancer drug (ABBV-467) is for the treatment of multiple myeloma in patients who have not responded or got worse on previous treatmentA First In Human Study of the MCL-1 Inhibitor, ABBV-467

Clinical summary


This trial contains two parts: dose escalation and dose expansion. Eligible patients will receive intravenous ABBV-467, either at a variable or recommended dose, depending on the part to which they are allocated.


This trial is treating patients with multiple myeloma.


Blood Cancers Haematological





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Scientific Title

A First In Human Study of the MCL-1 Inhibitor, ABBV-467



  • 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.


  • 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.


  • You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.


  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.

Clinical trials have complex eligibility criteria.

Ask your doctor if this trial could be right for you.

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