A Phase I/II Study of Personalized Neoantigen Vaccines in Advanced Solid Tumors

Full Title

An open-label, multicenter, dose escalation and expansion phase I/II study to evaluate the safety, tolerability, immunogenicity, and anti-tumor activity of patient-specific neoantigen vaccines as a single agent and in combination with pembrolizumab in patients with advanced or metastatic solid tumors

Purpose

Researchers want to create personalized vaccines for each patient based on their tumor’s unique genetic mutations. The vaccine is designed to train your immune system to recognize and attack your specific cancer cells. This study will test whether these custom vaccines are safe and effective when given alone or combined with immunotherapy drugs.

Primary Objectives

• Determine the safety profile and maximum tolerated dose of personalized neoantigen vaccines
• Evaluate the immune response generated by the vaccine against patient-specific tumor antigens
• Assess preliminary anti-tumor activity and clinical benefit rate

Diseases

• Breast Cancer
•  Lung Cancer
• Colorectal Cancer
• Pancreatic Cancer
• Advanced Solid Tumors