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
Patient capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
Male or female of > 18 years of age
Histologically confirmed diagnosis of metastatic or locally advanced solid tumour: • Colorectal carcinoma with MicroSatellite Stable colorectal carcinoma (MSS) not eligible for surgery or other ablative therapies. • Pancreatic adenocarcinoma not eligible for surgery or other ablative therapies.
ECOG performance status 0 or 1
Patients with >10% hepatic involvement as per investigator
Exposure to any investigational agent within 30 days of enrolment.
Concurrent enrolment in another clinical study, unless it is an observational (non-interventional) clinical study or during the follow-up period of an interventional study
History of any second malignancy within 2 years with the exception of malignancies with a negligible risk of metastasis or death (e.g. adequately treated carcinoma-in situ of the breast or the cervix, melanoma-in-situ, prostate cancer with Gleason grade ≤6 and prostate specific antigen within normal range).
Sequential
Personalized cancer vaccine including : DNA neoantigen vaccine, MVA viral vector and Ipilimumab (anti-CTLA4)
Biological/VaccineParticipants 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.
Phase 1 : Maximum Tolerated Dose (MTD) based on Dose Limiting Toxicity (DLT) (28 days) of ODI-2001 Phase 2 : Progression-Free Survival (PFS)
Phase 1 : The maximum tolerated Dose (MTD) is defined as the highest dose level of ipilimumab in comination with the ODI-2001 vaccine at which no more than 1 out of 6 patients experiences a dose Limiting Toxicities (DLT). DLT are assessed according to NCI-CTCAE (National Cancer Institute Common Terminology Criteria for Adverse Events) version 5.0 and include predefined hematologic and non-hematologic toxicities considerad related to ODI-2001 administration. If ≥ 2 patients in a cohort of up to 6 patients experience a DLT, the dose is considered above the MTD. Phase 2 : Progression-Free Survival (PFS) is defined as the time from the start of first-line chemotherapy to the first documented disease progression according to RECIST version 1.1 or death from any cause, whichever occurs first. PFS will be estimated using the Kaplan-Meier method.
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