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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

NCT07587827 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 77

Last updated 2026-05-14

No results posted yet for this study

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

Conditions

Interventions

BIOLOGICAL

Personalized cancer vaccine including : DNA neoantigen vaccine, MVA viral vector and Ipilimumab (anti-CTLA4)

Participants receive a combination therapy including DNA vaccine 4 mg IM, MVA 10⁷ pfu, and Ipilimumab IV at the dose assigned per arm: 2.5 mg, 5 mg, or 10 mg. Dose escalation is done sequentially in Phase I. The selected dose (RP2D) will be used in Phase II expansion.

Sponsors & Collaborators

  • Centre Georges Francois Leclerc

    lead OTHER

Principal Investigators

  • Jean-Marc JML LIMACHER, Dr · Odimma Therapeutics

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-11-01
Primary Completion
2027-05-01
Completion
2031-05-01

Countries

  • France

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07587827 on ClinicalTrials.gov