An Open Labelled First Human Dose Phase 1/2a Study to Evaluate Safety, Feasibility, Efficacy of Multiple Dosing With Individualised VB10.NEO Immunotherapy in Patients With Locally Advanced or Metastatic Melanoma, Non-small Cell Lung Cancer (NSCLC), Clear Renal Cell Carcinoma, Urothelial Cancer or Squamous Cell Carcinoma of Head and Neck, Who Did Not Reach Complete Responses With Current Standard of Care Immune Checkpoint Blockade
Phase of Trial: Phase I/II
Latest Information Update: 10 Oct 2018
At a glance
- Drugs VB10-NEO (Primary)
- Indications Head and neck cancer; Malignant melanoma; Non-small cell lung cancer; Renal cancer; Squamous cell cancer; Urogenital cancer
- Focus Adverse reactions; First in man
- Sponsors Vaccibody
- 10 Oct 2018 According to a Vaccibody media release, fist 10 patients has been enrolled in this study and vaccination is started.
- 24 Aug 2018 According to a Vaccibody media release, company received approval from the German regulatory authority- Paul Ehrlich Institute, of an amendment to the clinical trial application (CTA) allowing for CT-guided biopsies enabling more precise assessment of deep tumors.
- 06 Jun 2018 Planned number of patients changed from 91 to 65.