Cerulean Pharma has commenced a Phase II study of advanced gastric cancer drug CRLX101 by dosing the first patient.
The investigational anti-cancer agent, CRLX101, is designed to concentrate in tumours and release camptothecin over an extended period of time, prolonging drug exposure at the site of action.
Cerulean chief medical officer Dr Edward Garmey said; "We are fortunate to have another opportunity to collaborate with Drs Yen and Davis to further elucidate the tumour-targeting mechanism of nanopharmaceuticals and to potentially address the significant unmet medical need in gastric cancer."
The trial will assess the activity of CRLX101, a nanopharmaceutical dual inhibitor of topoisomerase 1 and hypoxia-inducible factor-1 alpha, in HER-2 negative gastric cancer patients with progressed disease subsequent to the standard frontline therapy.
Post-dosing tumour biopsies will assist in determining if CRLX101 is localised to human gastric tumour tissue.
The study is being conducted at City of Hope Comprehensive Cancer Center, Los Angeles, California.
City of Hope molecular pharmacology chair and study principal investigator Dr Yen said; "Despite promising advances in the continuing development of HER2-targeted therapies, the majority of gastric cancers are HER2 non-overexpressing, so new therapies are needed."
As a part of the Cerulean's CRLX101 clinical development programme, a randomised Phase II study conducted in 150 advanced non-small cell lung cancer patients is also being undertaken.