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news.Cerulean Pharma has dosed first patient in its Phase I/IIa trial of CRLX301 for the treatment of advanced solid tumor malignancies.
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The company uses its Dynamic Tumor Targeting Platform to create a portfolio of nanoparticle-drug conjugates (NDCs) designed to selectively attack tumor cells, reduce toxicity by sparing the body’s normal cells, and enable therapeutic combinations.
CRLX301 is a NDC with a docetaxel payload and it is the second clinical candidate from the company’s Dynamic Tumor Targeting Platform.
Cerulean executive chairman Paul Friedman said: "CRLX301 was superior to docetaxel in seven of seven animal models, with a statistically significant survival benefit in five of those preclinical models.
"We also saw preclinical tolerability that is consistent with our expectations of the platform — specifically, improved tolerability relative to published data with docetaxel. We look forward to learning if these preclinical results will translate in the clinic."
The Phase I/IIa trial is starting in Australia and is expected to expand to the US.
The single-arm, open-label, dose-escalation Phase I portion of the trial is conducted in about 36 patients with advanced solid tumor malignancies and is designed to identify the maximum tolerated dose and establish the recommended Phase II dose of CRLX301 when administered by intravenous infusion once every three weeks.
The trial’s Phase IIa portion will be an expansion group that will enroll an additional 24 patients.
The primary endpoints of the trial are pharmacokinetics, safety and tolerability of CRLX301.
Cerulean chief medical officer Edward Garmey said: "During the course of the CRLX301 clinical development program, we will carefully assess the investigational spaces in which currently approved taxanes can be improved through the targeted delivery of the cytotoxic payload to tumor cells and the relative sparing of healthy cells.
"We also are interested in those settings where taxanes haven’t been approved but where our NDC technology might facilitate their use, either alone or in combination."