COLONYVAQ™, a Quantum-Classical Guided Personalized Neoantigen Vaccine for MSS Stage III Colorectal Cancer

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 exp

Trial Details

NCT ID

NCT07328087

Phase

EARLY_PHASE1

Sponsor

Biogenea Pharmaceuticals Ltd.

Status

RECRUITING

Cancer Type

Colorectal Cancer

Interventions

Experimental: COLONYVAQ-CRC + mFOLFOX6 or CAPOX + Nivolumab

Locations (sample)

Thessaloniki, Greece|40.64072,22.93493

Key Eligibility Criteria

\*\*Diagnosis / Histology\*\*
Histologically confirmed adenocarcinoma of the colon or rectum.
Pathology report available for central or sponsor review (if requested), including:
Primary tumor site (colon vs rectum)

For full eligibility, visit ClinicalTrials.gov.

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