MagSense Anti-HER2 NPs( Imagion)

This Phase 1b/2 study is designed as an open-label, multicenter, 3 group, interventional study in which Phase 1b will evaluate the pharmacokinetics (PK) of MSH2IA and Phase 2 will confirm lowest effective dose as well as evaluate image timing, and diagnostic performance of a selected dose of MSH2IA when administered by subareolar or peritumoral injection.
No hypothesis testing is planned. Comparative statistics will be used to generate hypotheses to be tested in subsequent studies.