ArticleClinical cancer research : an official journal of the American Association for Cancer Research2026
First-in-Human, Open-label, Single-Arm Phase I Study of [211At] meta-Astatobenzylguanidine in Patients with Pheochromocytoma or Paraganglioma.
Article in Clinical cancer research : an official journal of the American Association for Cancer Research, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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Abstract
purposeThe efficacy of current therapeutic options for pheochromocytomas and paragangliomas, such as 131I-meta-iodobenzylguanidine (131I-MIBG), is limited owing to low complete response rates and a requirement for prolonged radiation isolation. In this regard, α-emitting meta-astatobenzylguanidine labeled with astatine-211 (211At-MABG) has demonstrated encouraging nonclinical results in mice, yet its clinical potential remains unclear. This first-in-human, open-label, single-arm phase I clinical study aimed to evaluate the safety, pharmacokinetics (PK), and recommended dose of 211At-MABG. PATIENTS AND
methodsTen participants with unresectable or metastatic treatment-refractory pheochromocytomas or paragangliomas and confirmed 123I-MIBG uptake were enrolled between June 2022 and May 2025. Using a 3 + 3 dose-escalation design (0.65, 1.3, and 2.1 MBq/kg), they received a single intravenous dose of 211At-MABG.
resultsNo dose-limiting toxicities were observed during the 6-week evaluation period. The cumulative urinary excretion of 211At-MABG reached 65% within 72 hours, indicating rapid systemic clearance. One, 7, and 2 patients exhibited a partial response (PR), stable disease, and progressive disease, respectively, during a maximum follow-up period of 12 weeks.
conclusionsA single dose of 211At-MABG at 2.1 MBq/kg was well tolerated and demonstrated predictable PK. Preliminary antitumor activity was observed, including 1 PR during the 12-week period. These findings establish the clinical feasibility of 211At-MABG and provide a translational foundation for multidose, dose-escalation, and biomarker-stratified trials.
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