Phase 1b Safety Run-In Study Followed by Phase 2 Study of...

Primary Objective:
Phase 1b:

To determine the feasibility of giving ficlatuzumab at 20 mg/kg in combination with venetoclax (Ven) and azacitidine (Aza) in newly diagnosed AML patients > or = 60 years old.
Phase 2:
To determine the complete remission (CR) rate, composite CR (cCR) [=CR, CR with hematologic improvement (CRh), CR with incomplete blood count recovery (CRi)] of this combination therapy in newly diagnosed AML patients > or = 60 years old examining two doses of ficlatuzumab.

Secondary Objectives:

To continue to determine the safety and tolerability of ficlatuzumab in combination with Ven and Aza.
To determine the 1-year overall survival (OS) and the event-free survival (EFS) in patients treated. Event-free survival is defined as the time from treatment start to the date of induction treatment failure or relapse for those who have induction treatment success or death from any cause, whichever occurs first.
To determine the duration of remission (DOR) in patients treated. Duration of remission is defined from the date patients first achieve CRi, CRh or CR to the date of progression or death, whichever occurs first.
To determine the percentage of patients that undergo hematopoietic stem cell transplant (HSCT).
To compare the CR and cCR rate of this combination therapy in newly diagnosed AML patients > or = 60 years old matched to a genetic Beat AML control population receiving Ven/Aza alone.
To characterize the pharmacokinetics of ficlatuzumab when administered in combination
with azacitidine and venetoclax.
To evaluate the immunogenicity of ficlatuzumab when administered in combination with azacitidine and venetoclax.

Exploratory Objectives:

To evaluate pharmacodynamics studies of ficlatuzumab in combination with Aza and Ven.
To possibly explore potential mechanisms of resistance to ficlatuzumab, Aza and Ven through genetic, transcriptional, proteomic and/or epigenetic analysis of paired leukemia samples.

Clinical Trial Details