NCT05018273

Study of VB10.NEO in Combination With Atezolizumab in Solid Tumors

A Phase 1B, Open-Label, Dose-Escalation Study of the Safety of and Antigen-specific Immune Responses Elicited by VB10.NEO in Combination With Atezolizumab in Patients With Locally Advanced and Metastatic Tumors

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 26 (actual)
• Sponsor: Nykode Therapeutics ASA · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

A phase 1b, open-label, multicenter, dose-escalation study designed to evaluate the safety, tolerability, antigen-specific immune response and preliminary antitumor activity associated with VB10.NEO administered in combination with atezolizumab, and to identify a RP2D for VB10.NEO in combination with atezolizumab, in patients with locally advanced and metastatic tumors that have progressed after at least 1 available standard therapy; or for whom standard therapy has proven to be ineffective or intolerable, or is considered inappropriate; or for whom a clinical trial of an investigational agent is a recognized standard of care (SOC).

Conditions

• Solid Tumors, Adult

Interventions

Type	Name	Description
BIOLOGICAL	VB10.NEO	The personalized vaccine VB10.NEO vaccine is given in combination with the PD-L1 inhibitor atezolizumab.

Timeline

• Start date: 2021-12-21
• Primary completion: 2024-10-09
• Completion: 2024-10-09
• First posted: 2021-08-24
• Last updated: 2024-12-03

Locations

12 sites across 3 countries: United States, Germany, Spain

Regulatory

• FDA-regulated drug study