Actively Recruiting
COLONYVAQ™, a Quantum-Classical Guided Personalized Neoantigen Vaccine for MSS Stage III Colorectal Cancer
Led by Biogenea Pharmaceuticals Ltd. · Updated on 2026-01-09
12
Participants Needed
1
Research Sites
304 weeks
Total Duration
On this page
Sponsors
B
Biogenea Pharmaceuticals Ltd.
Lead Sponsor
I
Interbalkan Medical Center, Thessaloniki, Greece
Collaborating Sponsor
AI-Summary
What this Trial Is About
This is an early phase I, single-arm, open-label clinical study designed to evaluate the safety, tolerability, and feasibility of COLONYVAQ-CRC, a physics-aware, quantum-classical AI-guided personalized neoantigen peptide vaccine, administered in combination with standard adjuvant oxaliplatin-based chemotherapy (mFOLFOX6 or CAPOX) and nivolumab 3 mg/kg in patients with completely resected stage III microsatellite-stable (MSS) / proficient mismatch repair (pMMR) colorectal cancer. An initial safety cohort of 12 patients will be enrolled and closely monitored for toxicity attributable to the experimental vaccine preparation. If, among these 12 patients, fewer than 3 develop experimental-preparation-related toxicity greater than grade 2 and no patient develops experimental-preparation-related grade 4 toxicity, the study will expand to enroll a total of 50 patients. Primary objectives focus on safety and tolerability of the combination regimen. Secondary and exploratory objectives characterize neoantigen-specific immune responses, ctDNA dynamics, T-cell receptor (TCR) clonotype evolution, tumor immune microenvironment features, and preliminary disease control (disease-free survival and overall survival) to inform subsequent phase II design.
CONDITIONS
Official Title
COLONYVAQ™, a Quantum-Classical Guided Personalized Neoantigen Vaccine for MSS Stage III Colorectal Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed adenocarcinoma of the colon or rectum
- Pathologic stage III disease (any T, N1-2, M0) per AJCC 8th edition
- Complete (R0) resection of primary tumor with no residual cancer
- No distant metastases (M1) on recent staging imaging
- Enrollment and treatment initiation within 4-12 weeks post-surgery
- Tumor confirmed microsatellite stable (MSS) or proficient mismatch repair (pMMR) by local testing
- At least one high-risk feature for recurrence (e.g., T4 tumor, N2 nodal status, positive postoperative ctDNA)
- Candidate for oxaliplatin-based adjuvant chemotherapy (mFOLFOX6 or CAPOX) with no contraindications
- Eligible to receive nivolumab 3 mg/kg IV every 2 weeks with no history of severe immune-related adverse events
- ECOG performance status 0-1
- Adequate hematologic, hepatic, and renal function within 14 days prior to enrollment
- Adequate tumor tissue available for neoantigen sequencing and analysis
- At least one predicted high-quality tumor neoantigen identified by COLONYVAQ pipeline or availability of pre-manufactured GMP-grade neoantigen peptides
- Investigator-estimated life expectancy of 3 years or more without recurrence
- Women of childbearing potential must have a negative pregnancy test and agree to use effective contraception
- Men with partners of childbearing potential must agree to use contraception and avoid sperm donation
- Able to understand and voluntarily sign informed consent and comply with study procedures
You will not qualify if you...
- Residual disease after surgery (R2 resection) or unclear margins
- Evidence of distant metastases (M1) at baseline staging
- Gross residual disease at primary tumor site
- Known mismatch repair-deficient (dMMR) or MSI-high colorectal cancer or POLE ultramutated tumors
- Prior systemic therapy for metastatic colorectal cancer
- Incomplete or toxic neoadjuvant chemotherapy outside protocol windows
- Prior tumor vaccine or immune checkpoint inhibitor therapy
- Active or uncontrolled infections including HIV, hepatitis B or C
- Severe or uncontrolled autoimmune disease requiring immunosuppression
- Prior allogeneic stem cell or solid organ transplantation
- Severe hypersensitivity to study drugs or vaccine components
- Active second primary malignancy requiring systemic therapy (with some exceptions)
- Significant unstable cardiovascular or pulmonary disease
- Serious uncontrolled medical conditions that may affect safety or adherence
- Pregnant or breastfeeding women
- Participation in other interventional trials with systemic investigational agents
- Recent live attenuated vaccine administration
- Psychiatric or social conditions limiting compliance or safety assessment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Biogenea Pharmaeuticals Ltd
Thessaloniki, Greece, 54627
Actively Recruiting
Research Team
I
Ioannis Grigoriadis, PharmacistPharmD
CONTACT
C
Christos Emmanouelides, MD, PhD, Medical Oncologist,
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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