ArticleClinical cancer research : an official journal of the American Association for Cancer Research2026
A phase I dose-escalation/expansion study of fractionated-dose and multiple cycle anti-PSMA-targeted alpha emitter 225Ac-J591 in patients with prostate cancer.
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
purposeTo test safety of two regimens at differing levels of radioactivity of PSMA-targeted alpha radionuclide 225Ac-J591. PATIENTS AND
methodsPatients with progressive, metastatic androgen pathway modulator resistant prostate cancer were enrolled in two parallel dose-escalation cohorts: (1) fractionated-dose regimen (single cycle of 45 - 65 KBq/kg of 225Ac-J591 on day 1 and day 15; main cohort agnostic to prior receipt of 177Lu-PSMA, additional cohort post 177Lu-PSMA) and (2) multiple cycles of 225Ac-J591 (45 - 65 KBq/kg administered every 6 weeks for up to 4 cycles). PSMA PET not utilized for eligibility. Primary end point was determination of dose-limiting toxicity (DLT) and recommended phase 2 dose (RP2D); the fractionated cohort was expanded.
results42 patients were enrolled in fractionated (23 dose-escalation, 11 expansion, 8 post 177Lu-PSMA), 18 multiple dose. All received > 1 prior AR pathway inhibitor, 72% chemotherapy, 18% 177Lu-PSMA. Three patients had DLT in fractionated regimen with RP2D of 60 KBq/kg x2. Seven had DLT in multiple cycle regimen; this regimen is not recommended for further development. Amongst adverse events of special interest, temporary hematologic toxicity was most common [93% thrombocytopenia (32% grade >3), 65% neutropenia (13% grade >3), 63% anemia (20% grade >3)]; dry mouth occurred in 62% (2% grade 2). Across fractionated cohorts with or without prior 177Lu-PSMA, 60% with >50% PSA decline as best response; 28% with >50% PSA decline in multiple cycle.
conclusionsFractionated dosing of 225Ac-J591 appears promising. Further investigation is underway.
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