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).
Single group
1 MBq/k of 211At-MABG Fractionated
DrugAstatine-211 \[211At\] is a short-lived α emitter conjugated onto meta-astatobenzylguanidine (\[211At\]MABG)
2 MBq/k1 of 211At-MABG Fractionated
DrugAstatine-211 \[211At\] is a short-lived α emitter conjugated onto meta-astatobenzylguanidine (\[211At\]MABG)
4 MBq/k of 211At-MABG Fractionated
DrugAstatine-211 \[211At\] is a short-lived α emitter conjugated onto meta-astatobenzylguanidine (\[211At\]MABG)
Evaluate overall study feasibility
Proportion of intended 211At-MABG fractionated doses that are successfully administered within the protocol-defined window (at the overall study level).
Evaluate study feasibility overall study feasibility assessed for operational issues versus treatment-related adverse events.
Proportion of fractionated dose administrations either delayed and/or omitted due to operational issues (i.e. insufficient/delayed synthesis) versus treatment-related adverse events (at the overall study level).
Safety of fractionated dosing of 211At-MABG in adults with advanced (PPGL) or other NET-overexpressing cancers per patient level
The proportion of intended 211At-MABG fractionated doses that are successfully administered within the protocol-defined window assessed at the 'per patient level'.
Safety of fractionated dosing of 211At-MABG in adults with advanced (PPGL) or other NET-overexpressing cancers per 'dose level'.
The proportion of intended 211At-MABG fractionated doses that are successfully administered within the protocol-defined window assessed at the 'per dose level'
The maximum tolerated dose (MTD) and/or Recommended Phase II Dose (RP2D) of 211At-MABG
Highest dose level at which 0 or 1 DLT occurs in 6 DLT-evaluable subjects
Incidence of Adverse Events
Type, frequency, severity, and attribution of adverse events. as assessed by CTCAE version 6.0
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University of Pennsylvania
Lead sponsor
National Institutes of Health (NIH)
Collaborator
National Cancer Institute (NCI)
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
