Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at La Jolla, California and other locations
Dates
study started
estimated completion

Description

Summary

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

Official Title

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

Keywords

Multiple Myeloma (MM) Cancer Relapse/Refractory ABBV-467 Multiple Myeloma Neoplasms, Plasma Cell

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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.

You CAN'T join if...

  • 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.

Locations

  • UCSD Moores Cancer Center - LaJolla /ID# 210075 not yet accepting patients
    La Jolla California 92093 United States
  • City of Hope /ID# 209786 not yet accepting patients
    Duarte California 91010 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
AbbVie
ID
NCT04178902
Phase
Phase 1
Study Type
Interventional
Last Updated