Avelas Biosciences announced the first patient has been dosed in its Phase 2 clinical trial of AVB-620 in women with primary, nonrecurrent breast cancer undergoing surgery.
"We're pleased to have begun dosing patients in our Phase 2 study of AVB-620 in women with breast cancer undergoing surgery, which marks a major milestone for Avelas," said Carmine Stengone, President & CEO of Avelas Biosciences. "This trial will allow us to confirm the findings from our Phase 1b trial, which demonstrated that AVB-620 could generate fluorescent signals that can distinguish breast cancer from adjacent tissues. We look forward to bringing this essential information to surgeons while they are still in the operating room."
This open-label, single-arm, Phase 2 study of AVB-620 is designed to evaluate 100 patients during two separate trial periods. Period 1 will have approximately 30 patients to evaluate conditions to achieve maximal differences in fluorescent signals between malignant and nonmalignant tissue. Period 2 will assess approximately 70 patients to test dosing and imaging conditions determined in Period 1, and the accuracy of AVB-620 imaging data to distinguish between malignant and nonmalignant tissues. Additional information about this clinical trial is available at clinicaltrials.gov using the identifier: NCT03113825.