Study Evaluating the Safety Feasibility and Efficacy of ODI-2001 Vaccine, a Personnalized Immunotherapy in Patients With Metastatic or Locally Advanced Colon Cancer or Pancreatic Cancer

This is a phase 1, open-label, multicentric study evaluating the safety, feasibility and efficacy of ODI-2001, a personnalized therapeutic cancer vaccine composed of DNA neoantigen vaccine, Modified Vaccinia virus Ankara (MVA) viral adjuvant and anti-CTLA4 (ipilimumab), in patients with metastatic or locally advanced colorectal or pancreatic cancer. The study includes a dose-escalation phase to determine the maximum tolerated dose (MTD) followed by an expansion phase to evaluate efficacy in terms of progression-free survival

NCT Number	NCT07587827
Lead Sponsor	Centre Georges Francois Leclerc
Conditions	Metastatic Colorectal Cancer (CRC), Locally Advanced Colorectal Cancer, Metastatic Pancreatic Cancer, Locally Advanced Pancreatic Cancer
Enrollment	77 participants
Start Date	2026-11-01
Primary Completion	2027-05-01 (estimated)
Study Completion	2031-05-01 (estimated)
Updated on ClinicalTrials.gov	2026-05-14