Solid Tumors, Adult Clinical Trial
Official title:
An Open-label, Phase I Multicenter, Clinical Trial of NECVAX-NEO1 in Addition to Anti-PD-1 or Anti-PD-L1 Monoclonal Antibody Checkpoint Inhibitor Monotherapy in Patients With Solid Tumors
NECVAX-NEO1 in addition to anti-PD-1 or anti-PD-L1 monoclonal antibody checkpoint inhibitor monotherapy in n=15 patients with solid tumors
The trial is conducted as a multi-centre, open label, single-arm phase 1 first-in-human trial to evaluate NECVAX-NEO1, a personalized investigational oral cancer immunotherapeutic investigational medicinal product in n=15 patients with solid tumors under anti-PD-1 or anti-PD-L1 monoclonal checkpoint inhibitor monotherapy. The trial has been designed to assess safety and tolerability of NECVAX-NEO1, at two dose levels as well as efficacy signals of NECVAX-NEO1 and immuno- and biomarkers in tumor tissue and blood samples pre- and post treatment. The trial will include patients with a diagnosis of either non-small cell lung cancer (NSCLC), melanoma, urothelial cancer, renal cell cancer (RCC), or squamous cell cancer of head and neck (SCCHN). Neoantigen epitopes as patient-individual tumor-specific drug targets will be selected and identified by the NEC OncoImmunity proprietary machine-learning and artificial intelligence technology. ;
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