U.S., Oct. 22 -- ClinicalTrials.gov registry received information related to the study (NCT07885683) titled 'MagSense(R) Human Epidermal Growth Factor Receptor 2 (HER2) Imaging Agent (MSH2IA)' on Oct. 13.
Brief Summary: 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.
Study Start Date: Nov. 30
Study Type: I...