Cerulean Pharma Inc., a clinical-stage company developing nanoparticle-drug conjugates (NDCs), today announced that the first patient has been dosed in the Phase 2a stage of an ongoing Phase 1/2a clinical trial of CRLX301 in patients with advanced solid tumors.
“Advancing CRLX301 into Phase 2a is a significant milestone for our second platform-generated NDC,” stated Christopher D. T. Guiffre, President & Chief Executive Officer of Cerulean. “We will further explore the once every-three-weeks dosing schedule at the Phase 1 established maximum tolerated dose in the Phase 2a expansion, while we continue the escalation study of weekly dosing in the ongoing Phase 1 stage. Our goal is to move into a pivotal study once the preferred dosing regimen and indication have been determined.”
This Phase 2a expansion includes two stages. Stage 1 will enroll up to 8 patients in each dosing schedule. This stage of the study is designed to further establish the safety and tolerability of each dosing schedule and to provide additional data on pharmacokinetics, pharmacodynamics and antitumor activity. Stage 2 will enroll up to 36 additional patients with specific tumor types using the optimal dosing schedule.