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.
Phase of Trial: Phase I
Latest Information Update: 25 Sep 2018
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
- 14 Sep 2018 Planned primary completion date changed from 1 Dec 2018 to 1 Apr 2019.
- 21 Jun 2017 New trial record