multiple myeloma (MM), Acute Myeloid Leukemia (AML)
Conditions
Interventions
investigational material(s)
Generic name etc : ABBV-467
INN of investigational material : -
Therapeutic category code : 429 Other antitumor agents
Dosage and Administration for Investigational materia
Sponsors
AbbVie GK
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - 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.
Exclusion criteria
Exclusion criteria: - 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| pharmacokinetics safety 1. Number of Participants with Adverse Events 2. Maximum Observed Plasma Concentration (Cmax) 3. Terminal Phase Elimination Half-life (t1/2) 4. Area Under the Plasma Concentration-Time Curve (AUCt) 5. Area Under the Plasma Concentration-Time Curve (AUCinf) 6. Clearance of ABBV-467 | — |
Secondary
| Measure | Time frame |
|---|---|
| efficacy For MM, efficacy will be evaluated per adapted International Myeloma Working Group (IMWG)5 criteria. 1. Overall Response Rate (ORR) For MM patients, ORR evaluated per adapted International Myeloma Working Group (IMWG) criteria and defined as partial remission (PR) + very good partial response (VGPR) + complete remission (CR) + stringent complete response (sCR). 2. Clinical Benefit Rate (CBR) CBR evaluated per adapted International Myeloma Working Group (IMWG) criteria and is defined as minimal response (MR) + PR + VGPR + CR + sCR. 3. Duration of Response (DOR) DOR is defined as the time between date of first response and the first occurrence of progression or death from any cause, whichever comes first. For AML, efficacy will evaluated per adapted International Working Group (IWG)6 and European Leukemia Net (ELN)7 criteria: 1. Composite complete remission (CRc), comprised of CR + CR with incomplete blood count recovery (CRi). 2. CR + CR with partial hematologic recovery (CRh). 3. ORR, comprised of CRc + PR. 4. DOR, as defined above. | — |
Countries
Asia except Japan, Europe, Japan, North America, Oceania
Outcome results
None listed