HEAT Trial (HER2 Antibody Therapy With Lutetium-177)

Participants who have any other known, active malignancy, except for treated cervical intraepithelial neoplasia, or nonmelanoma skin cancer. Participants with a history of malignancies of low recurrence potential who have received curative-intent therapy may be approved on a case-by-case basis in discussion with the study Sponsor, if it is determined not to put the participant at an increased risk of adverse drug effects and/or interfere with the integrity of study outcome.

Participants who have any medical condition that would, in the Investigator's judgment, prevent the participant's full participation in the clinical study due to safety concerns or compliance with clinical study procedures such as participants with severe claustrophobia who are unresponsive to oral anxiolytics, participants with low back pain who cannot lie comfortably on an imaging table, participants who are hyperactive or hyperkinetic such that they cannot tolerate lying still for multiple time-point imaging procedures, etc.

Residual toxicity Grade ≥ 2 from previously administered therapy (except for alopecia). Patients with Grade 2 or higher toxicity due to prior treatment may be allowed on a case-by-case basis in discussion with study Sponsor provided it is deemed not to put the participant at a higher risk of treatment-related toxicity or interfere with the integrity of study data, e.g., participants with endocrinopathy on stable replacement therapy

Creatinine clearance or Body Surface Area (BSA) adjusted Estimated glomerular filtration rate (eGFR) (calculated using any clinically validated formula, preferably Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI), or measured) < 60 mL/min