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 Liver Metastases From Colorectal Cancer
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 Colorectal cancer; Liver metastases
- Focus Adverse reactions; First in man
- Sponsors Alfasigma; sigma-tau SpA
- 01 Jul 2019 Status changed from recruiting to discontinued.
- 08 Mar 2019 Planned End Date changed from 1 Jun 2019 to 1 Jul 2019.
- 08 Mar 2019 Planned primary completion date changed from 1 Jan 2019 to 1 May 2019.