Actively Recruiting
Early Phase I Study of COLONYVAQ-CRC, a Personalized Quantum-Classical AI-Guided Neoantigen Vaccine Combined With Standard Oxaliplatin-Based Chemotherapy and Nivolumab in Patients With Resected Stage III Microsatellite-Stable Colorectal Cancer
Led by Biogenea Pharmaceuticals Ltd. · Updated on 2026-01-09
12
Participants Needed
1
Research Sites
52 weeks
Total Duration
AI-Summary
What this Trial Is About
Researchers are evaluating COLONYVAQ-CRC, a personalized neoantigen peptide vaccine using a physics-aware, quantum-classical AI-guided system, combined with standard oxaliplatin-based chemotherapy and nivolumab in patients with completely resected stage III microsatellite-stable colorectal cancer. This early phase I, single-arm, open-label study aims to assess the safety, tolerability, and feasibility of this combination treatment, while also exploring immune response and preliminary disease control. The study includes an initial safety cohort followed by an expansion phase if safety criteria are met. All participants receive the COLONYVAQ-CRC vaccine, consisting of up to 20 personalized peptides selected through advanced quantum-classical methods and mixed with an immune-stimulating agent for subcutaneous injection on a prime-boost schedule. This vaccine is given alongside standard adjuvant chemotherapy either mFOLFOX6 every 14 days for about 6 months or CAPOX every 21 days for 3 to 6 months and nivolumab infusions every 2 weeks for up to 12 months. The combination is designed to enhance immune activation by increasing tumor antigen presentation and supporting T-cell function. Participants will be closely monitored throughout the study for treatment-related side effects and immune responses over approximately 12 months. Assessments include blood samples for circulating tumor DNA and immune monitoring, imaging to check for cancer recurrence, quality of life questionnaires, and analysis of tumor immune environment. Follow-up extends up to 5 years for overall survival evaluation, with comprehensive safety and feasibility data collected to guide future research.
CONDITIONS
Brief Title
COLONYVAQ™, a Quantum-Classical Guided Personalized Neoantigen Vaccine for MSS Stage III Colorectal Cancer
Research Team
I
Ioannis Grigoriadis, PharmacistPharmD
C
Christos Emmanouelides, MD, PhD, Medical Oncologist,
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