Phase I dose escalation study of 211At-MABG in adults with advanced pheochromocytoma / paraganglioma (PPGL) or other NET-overexpressing cancers (as evidenced by positive MIBG imaging) who are refractory to, lacking, or ineligible for approved treatments. Phase 1 dose-escalation will follow a standard 3+3 design with an expansion cohort at the recommended phase two dose (RP2D).
Adult patients, at least 18 years of age
Advanced neuroendocrine cancers requiring systemic therapy and refractory to, ineligible for, declining, or lacking standard treatments.
I MIBG imaging indicating MIBG-avid disease (radiotracer uptake above background in at least one tumor site) per Investigator/Sub-Investigator assessment.
Participants must provide written informed consent prior to study-specific procedures.
Women who are pregnant or breast-feeding will not be eligible for this study.
Inability to tolerate study procedures in the opinion of the investigator or treating physician.
Serious or unstable medical, psychological, or social conditions that, in the opinion of the investigator, would compromise the subject's safety or successful participation in the study.
Uncontrolled brain metastasis (Participant must be at least 4 weeks since CNS-directed therapy and no longer requiring corticosteroid therapy).
University of Pennsylvania
Lead sponsor
National Institutes of Health (NIH)
Collaborator
National Cancer Institute (NCI)
Collaborator