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

Sponsor
Centre Georges Francois Leclerc
Study ID
NCT07587827
Phase
PHASE1
Status
Not Yet Recruiting

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Conditions

  • Locally Advanced Colorectal Cancer
  • Locally Advanced Pancreatic Cancer
  • Metastatic Colorectal Cancer (CRC)
  • Metastatic Pancreatic Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

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

Key Dates

Start date
Nov 1, 2026
Status verified
May 2026
Primary completion
May 1, 2027
Completion
May 1, 2031

Study Design

Enrollment
77 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Level 1 - Ipilimumab (Anti-CTLA4): 2.5 mg
    Participants recevront la dose de départ : DNA vaccine 4 mg, MVA 10⁷ pfu, Ipilimumab 2.5 mg (Anti-CTLA4). This arm may be expanded in Phase II if dose is selected as RP2D (Recommended Phase 2 Dose)
  • Experimental: Level 2 - Ipilimumab 5 mg
    Participants recevront DNA vaccine 4 mg, MVA 10⁷ pfu, Ipilimumab 5 mg (Anti-CTLA4).This arm may be expanded in Phase II if dose is selected as RP2D (Recommended Phase 2 Dose)
  • Experimental: Level 3 - Ipilimumab 10 mg
    Participants recevront DNA vaccine 4 mg, MVA 10⁷ pfu, Ipilimumab 10 mg (Anti-CTLA4). This arm may be expanded in Phase II if dose is selected as RP2D (Recommended Phase 2 Dose)

Primary Outcome Measure

Phase 1 : Maximum Tolerated Dose (MTD) based on Dose Limiting Toxicity (DLT) (28 days) of ODI-2001 Phase 2 : Progression-Free Survival (PFS) [ Time Frame: Phase 1 : within 28 days following the first administration of ODI-2001 Phase 2 : Up to 14 months for colorectal cancer cohort and up to 10 months for pancreatic cancer cohort following initiation of chemotherapy. ]

Central Contacts

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