drugset / Trial / NCT07587827
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
Non-randomizedSequentialOpen-labelTreatment
Summary
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
Timeline
- Start
- 2026-11-01
- Primary completion
- 2027-05-01
- Completion
- 2031-05-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Ipilimumab | Monoclonal antibody | 2.5 mg | Intravenous |
| Subject | Ipilimumab | Monoclonal antibody | 5 mg | Intravenous |
| Subject | Ipilimumab | Monoclonal antibody | 10 mg | Intravenous |
| Background | DNA neoantigen vaccine | Vaccine | 4 mg | Intramuscular |
| Background | Modified Vaccinia virus Ankara | Unknown | 1e+07 unknown | — |