AVEO Oncology, an LG Chem company, has announced that the first patient has been successfully dosed in a Phase 1b/2 clinical trial testing ficlatuzumab in combination with azacitidine and venetoclax for adults aged 60 and older with untreated acute myeloid leukemia (AML). 

 

The trial is conducted under a Master Clinical Trial Collaboration Agreement with Blood Cancer United, formerly the Leukemia & Lymphoma Society.

 

As part of the collaboration, Blood Cancer United is sponsoring the trial as a sub-study within its Beat AML Master Clinical Trial—the first precision medicine clinical trial in blood cancer that evaluates multiple therapies across several study arms simultaneously.

 

The trial aims to assess the safety, pharmacokinetics, pharmacodynamics, and preliminary efficacy of the combination therapy. Ficlatuzumab, AVEO’s investigational humanized IgG1 monoclonal antibody, targets the hepatocyte growth factor (HGF) ligand, blocking its signaling through the c-Met receptor. 

 

Previous early-phase studies of ficlatuzumab with cytarabine showed a favorable safety profile and promising clinical activity, particularly for patients unfit for standard intensive first-line therapy.

 

“This is a significant milestone for AVEO and Blood Cancer United, who are both dedicated to improving patient outcomes through novel clinical research,” said Michael P. Bailey, President and CEO of AVEO. “We welcome this partnership and are excited to collaborate on this important clinical trial as we continue to expand our efforts to address high unmet medical needs with our novel clinical stage portfolio of therapies.”

 

Lore Gruenbaum, Chief Scientific Officer of Blood Cancer United, added: “The Beat AML Master Clinical Trial seeks to change the paradigm for how this deadly cancer is treated, using an innovative precision medicine protocol and implementing strategic partnerships. Our collaboration with AVEO is a key next step for the trial and transforming patient care for adults with AML.”