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Phase 1 Trial With GD2-SADA:177Lu-DOTA Drug Complex in Patients With Recurrent or Refractory Metastatic Solid Tumors Known to Express GD2, Including Small Cell Lung Cancer, High Risk Neuroblastoma, Sarcoma and Malignant Melanoma

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Trial Profile

Phase 1 Trial With GD2-SADA:177Lu-DOTA Drug Complex in Patients With Recurrent or Refractory Metastatic Solid Tumors Known to Express GD2, Including Small Cell Lung Cancer, High Risk Neuroblastoma, Sarcoma and Malignant Melanoma

Status: Recruiting
Phase of Trial: Phase I

Latest Information Update: 02 Jun 2025

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At a glance

  • Drugs GD2-SADA (Primary) ; Lutetium-(177Lu)-oxodotreotide (Primary)
  • Indications Malignant melanoma; Neuroblastoma; Sarcoma; Small cell lung cancer; Solid tumours
  • Focus Adverse reactions; First in man
  • Acronyms SADA Y-PRIT
  • Sponsors Y-mAbs Therapeutics

Most Recent Events

  • 28 May 2025 According to a Y-mAbs Therapeutics Media Release, Part A of the trial is completed, Company plans to initiate a Trial 1001 Bridge study (Part 2A) with optimized Radiohapten, in 1H 2026 with data readout in 2H 2026; Part B of Trial 1001 anticipated to initiate with Proteus in 1H 2027 with data readout in 2H 2027.
  • 26 May 2025 According to a Y-mAbs Therapeutics Media Release, data from this study presented at the Advances in Neuroblastoma Research Meeting (ANR) being held on May 25-28, 2025 in Washington, D.C.
  • 13 May 2025 According to a Y-mAbs Therapeutics Media Release, Y-mAbs plans to host a virtual Radiopharmaceutical R&D update on Wednesday, May 28, 2025 where Part A clinical data from this ongoing trial will be discussed.

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