Publications

CAM-H2 is a novel radiopharmaceutical comprising of a single-domain antibody which binds to HER2, and that is covalently linked to the beta particle-emitting radioisotope I-131. The dose escalation phase of this study has a 3+3 design and was set up to assess safety, dosimetry, and PD of ascending doses of CAM-H2.

Medical monitoring is an essential aspect of clinical trials, as it helps ensure the safety and well-being of the participants. The primary role of medical monitoring is to identify and manage any adverse events that may occur during the trial. This includes monitoring the participants for any side effects of the study drug or treatment, as well as any other potential health risks that may be associated with the trial.

Clinical Development typically involves the following stages: Preclinical Development, Investigational New Drug (IND) Application, Phase 1 Clinical Trials, Phase 2 Clinical Trials, Phase 3 Clinical Trials, New Drug Application (NDA), and Post-approval Studies