US-based Cerulean Pharma has dosed the first patient in the ongoing Phase IIa stage of Phase I/IIa clinical trial of its nanoparticle-drug conjugate (NDC), CRLX301, to treat advanced solid tumours.
The Phase IIa is divided into two stages, and around eight patients will be enrolled in the first stage for each dosing schedule.
The first stage is intended to evaluate the safety and tolerability of CRLX301, as well as determine its pharmacokinetics, pharmacodynamics and antitumour activity.
In the second stage, approximately 36 patients will be enrolled with specific tumour types using the optimal dosing schedule.
Cerulean president and CEO Christopher Guiffre said: "Advancing CRLX301 into Phase IIa is a significant milestone for our second platform-generated NDC.
"We will further explore the once every-three-weeks dosing schedule at the Phase I established maximum tolerated dose in the Phase IIa expansion, while we continue the escalation study of weekly dosing in the ongoing Phase I stage.
"Our goal is to move into a pivotal study once the preferred dosing regimen and indication have been determined."
The dynamically tumour-targeted NDC, CRLX301, targets the tumours and slowly releases its anti-cancer payload, docetaxel, inside tumour cells.
Preclinical studies have established that CRLX301 releases up to ten times more docetaxel into tumours compared to an equivalent milligram dose of commercially available docetaxel, and was similar to or better than docetaxel in seven of seven animal models, with a statistically significant survival benefit seen in five of those seven models.
Additionally, preclinical data has also exhibited that CRLX301 had lower toxicity.