211At-MABG in Adults With Advanced Neuroendocrine Cancers
University of Pennsylvania
Summary
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).
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Adult patients, at least 18 years of age 2. Advanced neuroendocrine cancers requiring systemic therapy and refractory to, ineligible for, declining, or lacking standard treatments. 3. I MIBG imaging indicating MIBG-avid disease (radiotracer uptake above background in at least one tumor site) per Investigator/Sub-Investigator assessment. 4. Participants must provide written informed consent prior to study-specific procedures. 5. ECOG performance status ≤ 2. 6. Adequate organ function including: 1. Hemoglobin ≥ 9 g/dL 2. Absolute neutrophil count ≥ 1,500/mm³ 3.…
Interventions
- Drug1 MBq/k of 211At-MABG Fractionated
Astatine-211 \[211At\] is a short-lived α emitter conjugated onto meta-astatobenzylguanidine (\[211At\]MABG)
- Drug2 MBq/k1 of 211At-MABG Fractionated
Astatine-211 \[211At\] is a short-lived α emitter conjugated onto meta-astatobenzylguanidine (\[211At\]MABG)
- Drug4 MBq/k of 211At-MABG Fractionated
Astatine-211 \[211At\] is a short-lived α emitter conjugated onto meta-astatobenzylguanidine (\[211At\]MABG)
Location
- University of Pennsylvania - Abramson Cancer CenterPhiladelphia, Pennsylvania