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A Dose Escalation Study to Evaluate Safety, Tolerability, Pharmacokinetics, Dosimetry, Maximum Tolerated Dose and Preliminary Efficacy of Intra-lesionally Injected AvidinOX, Followed by Systemic IV Administration of Escalating Doses of [177Lu]DOTA-biotin in Patients With Solid Tumors or Lymphomas With Injectable Neoplastic Lesions

Trial Profile

A Dose Escalation Study to Evaluate Safety, Tolerability, Pharmacokinetics, Dosimetry, Maximum Tolerated Dose and Preliminary Efficacy of Intra-lesionally Injected AvidinOX, Followed by Systemic IV Administration of Escalating Doses of [177Lu]DOTA-biotin in Patients With Solid Tumors or Lymphomas With Injectable Neoplastic Lesions

Status: Discontinued
Phase of Trial: Phase I

Latest Information Update: 08 Jul 2019

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At a glance

  • Drugs AvidinOx-Lu-177-DOTA-Biotin (Primary) ; Lutetium-177 biotin-DOTA (Primary)
  • Indications Lymphoma; Solid tumours
  • Focus Adverse reactions
  • Sponsors Alfasigma; sigma-tau SpA

Most Recent Events

  • 01 Jul 2019 Status changed from recruiting to discontinued.
  • 08 Mar 2019 Planned End Date changed from 1 Jun 2019 to 30 Jul 2019.
  • 08 Mar 2019 Planned primary completion date changed from 1 Apr 2019 to 30 Apr 2019.

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