Aveo Pharmaceuticals, a biotechnology company, has initiated a Phase Ib/IIa clinical trial of AV-951 as monotherapy for the treatment of advanced non-small cell lung cancer.
This new trial expands on the company’s broad development program for AV-951, a novel triple VEGF receptor inhibitor being studied in multiple single agent and combination clinical trials across a variety of cancer types including renal cell carcinoma, breast cancer, colorectal cancer and now, lung cancer.
The company has launched the Phase Ib portion of this new open-label study at leading cancer institutions in the US to evaluate continuous, escalating daily doses of oral AV-951 over four weeks in approximately 21 patients with recurrent or progressive non-small cell lung cancer (NSCLC), or who are non-responsive to standard therapy.
According to the company, safety, tolerability and maximum tolerated dose (MTD) will be observed as the primary outcomes of the Phase Ib portion of this Phase Ib/IIa trial. Once MTD is determined, the subsequent Phase IIa portion of the trial will evaluate over eight weeks the overall response rate to daily dosing with AV-951 in 21-41 patients with recurrent, progressive or non-responsive NSCLC and no prior exposure to anti-angiogenic therapy.
In parallel with this Phase Ib/IIa combination trial, AVEO will study global and targeted gene expression patterns in all patients to evaluate biomarkers for response and patient selection.
Tuan Ha-Ngoc, president and CEO of Aveo, said: This Phase Ib/IIa clinical trial of AV-951 is an important addition to our robust development program for AV-951, the breadth of which speaks to our confidence in this unique angiogenesis inhibitor to become a broadly used cancer therapy.