211At-MABG in Adults With Advanced Neuroendocrine Cancers
Part of paid clinical trials in Philadelphia, Pennsylvania.
- Sponsor
- University of Pennsylvania
- Study ID
- NCT07661420
- Phase
- PHASE1
- Status
- Not Yet Recruiting
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Conditions
- Bronchial Carcinoid
- Gastroenteropancreatic Neuroendocrine Neoplasm
- Medullary Thyroid Cancer
- Neuroendocrine Tumors
- Paraganglioma
- Pheochromocytoma
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- 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)
Study Details
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).
Key Dates
- Start date
- Aug 1, 2026
- Status verified
- Jun 2026
- Primary completion
- Aug 1, 2029
- Completion
- Aug 1, 2032
Study Design
- Enrollment
- 16 participants (estimated)
- Allocation
- NON_RANDOMIZED
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: Dose Level -1: Fractionated 211At-MABGOne treatment cycle (1 MBq/k) of 211At-MABG administered by IV administration in 4 fractionated (0.25 MBq/kg) weekly doses (+ 7 days) (one treatment cycle = 4 weekly fractionated doses).
- Experimental: Dose Level 1: Fractionated 211At-MABGOne treatment cycle (2 MBq/k) of 211At-MABG administered by IV administration in 4 fractionated (0.5 MBq/kg) weekly doses (+ 7 days) (one treatment cycle = 4 weekly fractionated doses).
- Experimental: Dose Level 2: Fractionated 211At-MABGOne treatment cycle (4 MBq/k) of 211At-MABG administered by IV administration in 4 fractionated (1 MBq/kg) weekly doses (+ 7 days) (one treatment cycle = 4 weekly fractionated doses).
Primary Outcome Measure
Evaluate overall study feasibility [ Time Frame: 4 weeks ]
Central Contacts
- Abramson Cancer Center
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| University of Pennsylvania - Abramson Cancer Center | Philadelphia | Pennsylvania | 19104 | Abramson Cancer Center Vivek Narayan, MD, MS (PRINCIPAL_INVESTIGATOR) |
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