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A Phase I/IIa, Dose Escalation and Dose Expansion, First-in-human, Open-label, Multicenter, Single-arm Study Evaluating the Safety, Tolerability, Dosimetry, and Early Efficacy of [177Lu]Lu-SN201 in Participants With Progressive or Treatment-refractory Locally Advanced Unresectable, Metastatic or Recurrent Solid Tumors

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A Phase I/IIa, Dose Escalation and Dose Expansion, First-in-human, Open-label, Multicenter, Single-arm Study Evaluating the Safety, Tolerability, Dosimetry, and Early Efficacy of [177Lu]Lu-SN201 in Participants With Progressive or Treatment-refractory Locally Advanced Unresectable, Metastatic or Recurrent Solid Tumors

Status: Recruiting
Phase of Trial: Phase I/II

Latest Information Update: 20 Dec 2024

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At a glance

  • Drugs 177 Lu SN 201 (Primary)
  • Indications Lung cancer; Prostate cancer; Rectal cancer; Solid tumours
  • Focus Adverse reactions; First in man; Therapeutic Use
  • Acronyms Tumorad; Tumorad-01
  • Sponsors Spago NanoMedical

    • Most Recent Events

    • 18 Dec 2024 According to a Spago Nanomedical media release, company announced that all patients in the second patient group have been dosed in this study. And we are now awaiting the DMC's analysis of this second group of patients early next year.
    • 06 Nov 2024 According to a Spago Nanomedical media release, the next cohort of patients in the Tumorad-01 study is ready for evaluation by DMC in the beginning of next year.
    • 06 Nov 2024 According to a Spago Nanomedical media release, the independent Data Monitoring Committee (DMC) recommended to proceed the clinical phase I/IIa study Tumorad-01 with the candidate drug 177Lu-SN201 according to plan. The recommendation is based on an analysis of data from the first three treated patients in the study that the DMC considers shows a satisfactory safety profile. The study proceeds according to plan with recruitment of patients at the two hospitals activated so far.

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