US-based clinical-stage company Cerulean Pharma has dosed the first patient in a randomised Phase 2 study of its anti-cancer drug for treating extensive-stage small cell lung cancer (SCLC).
The investigational tumor-targeted nanopharmaceutical, CRLX101, is a dual inhibitor of topoisomerase 1 and hypoxia-inducible factor-1a, which releases its payload, camptothecin, over an extended period of time.
The study, which has enroled 150 patients who are sensitive to first-line platinum-based chemotherapy, will assess whether CRLX101 can demonstrate enhanced efficacy with a favourable safety profile when compared to topotecan, a second-line therapy for relapsed SCLC.
The trial, which is being conducted at the University of Chicago School of Medicine and affiliated institutions, has co-primary endpoints of progression-free survival (PFS) and three-month PFS rate, according to the company.
During the company's preclinical and Phase 1/2a clinical trial, CRLX101 has demonstrated significant anti-tumor activity.
Cerulean Pharma chief medical officer Edward Garmey said relapsed SCLC is a treatment setting that has very limited therapeutic options.
"Our clinical experience with CRLX101 shows a benign safety profile," Garmey added.
"The standard of care in SCLC is not well tolerated, so if we can demonstrate an efficacy benefit versus standard of care, CRLX101 would have the added benefit of improved quality of life for these very sick patients."