First In Human Study of the MCL-1 Inhibitor, ABBV-467
- Conditions
- multiple myeloma (MM), Acute Myeloid Leukemia (AML)
- Registration Number
- JPRN-jRCT2080225038
- Lead Sponsor
- AbbVie GK
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- terminated
- Sex
- All
- Target Recruitment
- 25
Documented diagnosis of multiple myeloma (MM)or Acute Myeloid Leukemia (AML)
- For MM patients, Measurable disease defined as at least 1 of the following: serum
monoclonal protein >= 1g/dL or urine M-protein >= 200mg/24 hours
- Relapsed after or are refractory or intolerant to all established MM
therapies that are 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(For subjects with AML, the following hematologic parameter requirements are not
applicable.)
- Echocardiogram with ejection fraction >= 50% and no other clinically
significant findings that would increase the participant's susceptibility to
cardiac toxicity
- AML subjects only: Total white blood cell count < 25,000/mm3 (Note: hydroxyurea is
permitted to meet this criterion).
- For AML subjects only: failure to respond to, and/or relapse or progression after, at least
1 prior line of therapy, including all available standard therapies.
- Prior exposure to any targeted 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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method