NCT05354323

NECVAX-NEO1 in Addition to Checkpoint Inhibitor in Patients With Solid Tumors

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

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: NEC OncoImmunity AS · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

NECVAX-NEO1 in addition to anti-PD-1 or anti-PD-L1 monoclonal antibody checkpoint inhibitor monotherapy in n=6 patients with solid tumors

Detailed description

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=6 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.

Conditions

• Solid Tumors, Adult

Interventions

Type	Name	Description
BIOLOGICAL	NECVAX-NEO1	Oral Ty21a based T-cell vaccination, personalized patient-individual NECVAX-NEO1 constructs containing a eukaryotic expression plasmid encoding for a series of selected neoantigen epitopes

Timeline

• Start date: 2022-05-05
• Primary completion: 2025-12-31
• Completion: 2025-12-31
• First posted: 2022-04-29
• Last updated: 2025-06-26

Locations

3 sites across 1 country: Lithuania