ficlatuzumab (AV-299)

P3, N=410, Recruiting, AVEO Pharmaceuticals, Inc.

P3, N=410, Recruiting, AVEO Pharmaceuticals, Inc. | Not yet recruiting --> Recruiting

P3, N=410, Not yet recruiting, AVEO Pharmaceuticals, Inc.

P2, N=78, Completed, University of Arizona | N=60 --> 78

In this phase Ib trial, ficlatuzumab, gemcitabine, and albumin-bound paclitaxel were associated with durable treatment responses and increased rates of hypoalbuminemia and edema.

The ficlatuzumab-cetuximab arm met significance criteria for PFS and warrants phase III development. HPV-negative HNSCC merits consideration as a selection criterion.

P2; Active, not recruiting --> Completed

P2, N=74, Active, not recruiting, University of Arizona | Trial completion date: Dec 2021 --> May 2022 | Trial primary completion date: Dec 2021 --> May 2022

The ficlatuzumab and cytarabine combination is well-tolerated with favorable efficacy. High-dimensional analyses at single-cell resolution represent promising approaches for identifying biomarkers of response and mechanisms of resistance in prospective clinical studies.

P2, N=74, Active, not recruiting, University of Arizona | Trial completion date: May 2021 --> Dec 2021 | Trial primary completion date: May 2021 --> Dec 2021

P2, N=74, Active, not recruiting, University of Arizona | Recruiting --> Active, not recruiting | Trial completion date: Dec 2020 --> May 2021 | Trial primary completion date: Dec 2020 --> May 2021

An increase in peripheral T cells, particularly the CD8 subset, was associated with treatment response whereas progression was associated with expansion of a distinct myeloid population. This well-tolerated combination demonstrated promising activity in cetuximab-resistant, advanced HNSCC.

P1, N=17, Terminated, C. Babis Andreadis | Trial completion date: Jun 2020 --> Dec 2019 | Active, not recruiting --> Terminated; Low Accrual

P2 | "A Bayesian continuous monitoring rule for futility has not been triggered for either arm. Research Funding: Aveo"

The combination of ficlatuzumab with gemcitabine and nab-paclitaxel is associated with durable treatment responses but also significant hypoalbuminemia and edema that may impair treatment tolerability. Serial blood samples were collected for circulating HGF measurements, and mandatory pretreatment biopsies were collected for tumor c-MET pathway activation and 3D organoid culture drug sensitivity testing. Clinical trial information: NCT03316599.