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Reported Monday, Y-mAbs Highlights Ongoing Phase 1 Trial Of GD2-SADA PRIT With 177Lu-DOTA At ANR 2025 In Washington, D.C.

Benzinga·05/27/2025 06:24:14
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The trial in progress poster titled "A phase 1 trial of pretargeted radioimmunotherapy with GD2-SADA: 177Lu-DOTA in patients with high-risk neuroblastoma and other GD2+ solid tumors" provides an overview of Trial 1001 (NCT05130255), a first-in-human, dose-escalation, single-arm, open-label, nonrandomized, multicenter Phase 1 clinical trial evaluating the safety and tolerability of GD2-SADA Pretargeted Radioimmunotherapy ("GD2-SADA PRIT") with Lutetium 177 DOTA (177Lu-DOTA) in adult and adolescent patients (≥ 16 years of age and older) with recurrent or refractory metastatic GD2-expressing solid tumors, including high-risk neuroblastoma ("HR NB"), small cell lung cancer, sarcoma, and melanoma. Part A of the trial includes dose escalation of GD2-SADA protein to define the optimal safe dose of this self-assembling and disassembling protein and will also evaluate the administration interval between GD2-SADA and 177Lu-DOTA.