First-in-Human, Open-label, Single-Arm Phase I Study of [211At] meta-Astatobenzylguanidine in Patients with Pheochromocytoma or Paraganglioma.
Clin Cancer ResOct 1, 2026
Shozo Okamoto, Kaori Nomura, Tohru Shiga et al.
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In 30 seconds
This first-in-human, open-label, single-arm Phase I study evaluated the safety and pharmacokinetics of 211At-meta-astatobenzylguanidine (211At-MABG) in 10 patients with unresectable or metastatic pheochromocytomas or paragangliomas. The study found that 211At-MABG was well tolerated at a dose of 2.1 MBq/kg, with one patient achieving a partial response during a maximum follow-up of 12 weeks.
Key findings
- No dose-limiting toxicities were observed during the 6-week evaluation period.
- Cumulative urinary excretion of 211At-MABG reached 65% within 72 hours.
- One patient exhibited a partial response, while 7 had stable disease and 2 had progressive disease.
Why it matters
The study highlights the potential of 211At-MABG as a novel therapeutic option for patients with treatment-refractory pheochromocytomas and paragangliomas, addressing limitations of existing therapies.