Swedish biotechnology company Alligator Bioscience AB (STO:ATORX) reported on Thursday that the first patient has been dosed in an investigator-initiated trial evaluating intratumoural administration of its lead CD40 agonist, mitazalimab, in patients with early-stage breast cancer.
Conducted at an Ivy League university in the United States, the study is assessing mitazalimab as a single intratumoural dose, either alone or in combination with a single intratumoural dose of nivolumab, prior to surgery.
The trial is designed to evaluate how local CD40 activation affects the tumour microenvironment to support future clinical development. Primary endpoints are safety and feasibility, while secondary and exploratory objectives include pathological and imaging-based measures of anti-tumour activity and analyses of immune activation within the tumour microenvironment.
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