Metastatic Colorectal Cancer (CRC)Phase 1ODI-2001-01NCT07587827
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
A Phase 1 study testing Personalized cancer vaccine including : DNA neoantigen vaccine, MVA viral vector and Ipilimumab (anti-CTLA4) in people with Metastatic Colorectal Cancer (CRC) and Locally Advanced Colorectal Cancer, run by Centre Georges Francois Leclerc at 2 sites in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Colorectal Cancer (CRC), Locally Advanced Colorectal Cancer, Metastatic Pancreatic Cancer
- What is being tested?
- Personalized cancer vaccine including : DNA neoantigen vaccine, MVA viral vector and Ipilimumab (anti-CTLA4)
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 77 participants
- Where
- 2 sitesFrance
- Study dates
- 1 Nov 2026to 1 May 2031
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
- Baseline Tumoral evaluation (thoraco-abdomino-pelvic computed tomography) performed before the initiation of the standard first line-chemotherapy with at least one measurable lesion according to RECIST 1.1 criteria that can be accurately assessed at baseline and is suitable for repeated assessment.
- Eligible to start a standard first line chemotherapy indicated in colorectal cancer (FOLFOX/FOLFIRI/FOLFIRINOX or FOLFOXIRI +/- anti-VEGF/EGF) pancreatic cancer (FOLFIRINOX/NabPaclitaxel-Gemcitabine).
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- Adequate haematological, renal and hepatic laboratory requirements : • Haemoglobin > 9.0 g/dL • White Blood Cells (WBC) > 2.5x109/L including, absolute neutrophils count (ANC) > 1.5x109/L, total lymphocytes count > 0.5x109/L • Platelet's count > 100x109/L• Serum alkaline phosphatase (PAL) ≤ 3 x ULN in the absence of liver or bone metastases and ≤ 5 x ULN in patients with documented bone or liver metastases• Serum transaminases (alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 x ULN in the absence of liver metastases and ≤ 5 x ULN in case of liver metastases
- Total bilirubin ≤ 1.5 x ULN• Albumin ≥ 30 g/L • Glomerular Filtration Rate ≥ 50 mL/min (according to Modification of the Diet in Renal Disease [MDRD] formula or Cockroft \& Gault formula)
- Adequate cardiac function with QTc < 450 msec on baseline ECG, using the Fridericia correction cQTcF formula
- Life expectancy of at least 6 months
- Patient willing and able to comply with scheduled visits and exams during the follow-up and treatment compliance of the protocol, for the duration of the study including : • mandatory blood sampling (3 blood sampling) • mandatory biopsy of the tumor following enrolment in STEP 1 if no archived material dated less than 2 years is available in sufficient quality or quantity and a mandatory biopsy at 2 months after the initiation of ODI-2001 vaccine administration.
- Men who are sexually active with women of childbearing potential must agree to use contraceptive method during the ODI-2001 treatment period and for at least 4 months after the last ODI-2001 administration. The individual methods of contraception may be determined in consultation with the investigator and it must have a failure rate of less than 1% per year.
- A female participant is eligible to participate if she is not pregnant (negative urinary or serum pregnancy test), not breastfeeding, and at least one of the following conditions applies: • Not a woman of childbearing potential OR • Women of childbearing potential who agrees to apply effective contraception method during the treatment period and for at least 4 months after the last dose of study treatment. Effective contraception methods include a combination of any of the following (unless method is abstinence or sterilization, in which only one method is required): - Use of oral, injected, or implanted hormonal methods of contraception, or other forms of hormonal contraception that have comparable efficacy (failure rate < 1%). In case of use of oral contraception, women should have been stable on the same pill for a minimum of 6 months before taking study treatment. - Placement of an intrauterine device or intrauterine system. - Barrier methods of contraception: condom or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/vaginal suppository. - Total abstinence - Female sterilization at least eight weeks before taking study treatment. - Male sterilization (at least six months prior to screening)
- Patient must be affiliated to a social health insurance regimen
- First tumoral evaluation shows disease response with the following definition:
- Colorectal carcinoma: A decrease of at least 30% or more in the sum of the diameters of target lesions compared to the initial sum of diameters (Baseline assessment) = at least partial response definition according to RECIST 1.1 definition.
- Pancreatic carcinoma: A decrease of at least 20% or more in the sum of the diameters of target lesions compared to the initial sum of diameters (Baseline assessment) = adaptative RECIST 1.1 definition.
- Availability of tumoral material in sufficient quality and quantity in FFPE to performed dB209 manufacturing (5-10 slides according to tissue surface area) + tumoral microenvironment assessment (10 slides). In case of lack of tumoral material to performed the mandatory 2 analysis, a new biopsy should be organized.
- Second tumoral evaluation shows disease response with the following definition:
- Colorectal carcinoma: A decrease of at least 30% or more in the sum of the diameters of target lesions compared to the initial sum of diameters (Baseline assessment) = at least partial response definition according to RECIST 1.1 definition.
- Pancreatic carcinoma: A decrease of at least 20% or more in the sum of the diameters of target lesions compared to the initial sum of diameters (Baseline assessment) = adaptative RECIST 1.1 definition.
- Patient eligible for a 6-week chemotherapy break, with the start of maintenance treatment beginning in week 7.
Who cannot join
- 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).
- Known or suspected history of immunosuppression (severe auto-immune or immunodeficiency disease) including history of invasive opportunistic infections (e.g tuberculosis, histoplasmosis, listeriosis, coccidioidomycosis, pneumocystis, aspergillosis) despite infection resolution. Presence or suspicion of active bacterial, fungal or viral infections, or uncontrolled fever
- Patients with major surgery within 4 weeks from enrolment
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- Previous vaccination (either therapeutic and/or prophylactic) against cancer
- Any unresolved toxicity NCI CTCAE Grade ≥2 from previous anticancer therapy with the exception of alopecia, ototoxicity, vitiligo, and the laboratory values defined in the inclusion criteria.
- Patients under chronic treatment with systemic corticoids or other immunosuppressive drugs (e.g., cyclosporine) unless used at dose levels that are not immunosuppressive (e.g. Prednisone at 10 mg/day or less or as inhaled steroid at doses used for the treatment of asthma) up to 14 days before pre-enrolment.
- Is receiving growth factors including, but not limited to, granulocyte colony stimulating factor (G-CSF), granulocyte macrophage-colony stimulating factor (GM-CSF), erythropoietin, etc. within 4 weeks from enrolment
- Known history of Positive serology for Human Immunodeficiency Virus (HIV) or Hepatitis C Virus (HCV); presence of HBs antigen in the serum
- History of severe auto-immune or immunodeficiency disease
- Known allergy to any of the components of ODI-2001 (e.g. egg or gentamycin)
- Known allergy, or history of serious adverse reaction to vaccines such as anaphylaxis, hives, or respiratory difficulty
- Planned to receive yellow fever or other live (attenuated) vaccines during the course of the study
- Recent or active clinically significant infection requiring therapy at the time of first dose
- Any persistent or unresolved drug-related toxicity following previous treatment
- Myocardial infarction or stroke within previous 6 months, unstable angina, serious uncontrolled cardiac arrhythmia, history of myocarditis, or congestive heart failure
- Known symptomatic malignant brain lesion
- Patients with any serious uncontrolled disease or psychiatric condition that, in the opinion of the Investigator, might interfere with the patient's participation in the trial or interfere with the interpretation of trial results
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France2 sites
CHRU Jean Minjoz
Besançon, 25000
Christophe CB BORG, Professor, 03 81 47 99 99 ext. +33, Xtophe.borg@gmail.com
Centre Georges-François Leclerc
Dijon, 21000
François FG Ghiringhelli, Professor, 03 45 34 75 38 ext. +33, fghiringhelli@cgfl.fr
About this study
Official title: A Phase 1, Open-label, Dose-escalation and Dose-expansion 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
- Conditions
- Metastatic Colorectal Cancer (CRC), Locally Advanced Colorectal Cancer, Metastatic Pancreatic Cancer, Locally Advanced Pancreatic Cancer
- Being tested
- Personalized cancer vaccine including : DNA neoantigen vaccine, MVA viral vector and Ipilimumab (anti-CTLA4)
- Keywords
- vaccine, pancreas, colorectal, phase 1
- Medical subject headings
- Colorectal Neoplasms, Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Personalized cancer vaccine including : DNA neoantigen vaccine, MVA viral vector and Ipilimumab (anti-CTLA4)Biological
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.
| Study group | Role | What they receive |
|---|---|---|
| Level 1 - Ipilimumab (Anti-CTLA4): 2.5 mg | Experimental | 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) Receives: Biological: Personalized cancer vaccine including : DNA neoantigen vaccine, MVA viral vector and Ipilimumab (anti-CTLA4) |
| Level 2 - Ipilimumab 5 mg | Experimental | 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) Receives: Biological: Personalized cancer vaccine including : DNA neoantigen vaccine, MVA viral vector and Ipilimumab (anti-CTLA4) |
| Level 3 - Ipilimumab 10 mg | Experimental | 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) Receives: Biological: Personalized cancer vaccine including : DNA neoantigen vaccine, MVA viral vector and Ipilimumab (anti-CTLA4) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2026
- Study start1 Nov 2026 (estimated)
- Primary completion1 May 2027 (estimated)
- Study completion1 May 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Colorectal Cancer (CRC)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- First : Dose escalation And then, Expansion phase
- Masking
- None (open label)
- Enrolment
- 77 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Georges Francois Leclerc
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean-Marc JML LIMACHER, Dr, Study chair, Odimma Therapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07587827
- Sponsor's protocol ID
- 2025-523172-23-00
- Other IDs
- 2025
- Acronym
- ODI-2001-01
- Status last verified
- May 2026
- First submitted
- 4 May 2026
- Last updated
- 14 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-label, Dose-escalation and Dose-expansion 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
- ClinicalTrials.gov ID
- NCT07587827
- Acronym / sponsor ID
- ODI-2001-01 / 2025-523172-23-00
- Conditions
- Metastatic Colorectal Cancer (CRC), Locally Advanced Colorectal Cancer, Metastatic Pancreatic Cancer, Locally Advanced Pancreatic Cancer
- Keywords
- vaccine, pancreas, colorectal, phase 1
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 77 participants (estimated)
- Lead sponsor
- Centre Georges Francois LeclercUniversity, hospital or other
- Study start
- 1 Nov 2026 (estimated)
- Primary completion
- 1 May 2027 (estimated)
- Study completion
- 1 May 2031 (estimated)
- First posted
- 14 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- First : Dose escalation And then, Expansion phase
| Arm | Type | Receives |
|---|---|---|
| Level 1 - Ipilimumab (Anti-CTLA4): 2.5 mg | Experimental | Biological: Personalized cancer vaccine including : DNA neoantigen vaccine, MVA viral vector and Ipilimumab (anti-CTLA4)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) |
| Level 2 - Ipilimumab 5 mg | Experimental | Biological: Personalized cancer vaccine including : DNA neoantigen vaccine, MVA viral vector and Ipilimumab (anti-CTLA4)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) |
| Level 3 - Ipilimumab 10 mg | Experimental | Biological: Personalized cancer vaccine including : DNA neoantigen vaccine, MVA viral vector and Ipilimumab (anti-CTLA4)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) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (22 listed)
- 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
- Baseline Tumoral evaluation (thoraco-abdomino-pelvic computed tomography) performed before the initiation of the standard first line-chemotherapy with at least one measurable lesion according to RECIST 1.1 criteria that can be accurately assessed at baseline and is suitable for repeated assessment.
Key exclusion criteria (20 listed)
- 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).
- Known or suspected history of immunosuppression (severe auto-immune or immunodeficiency disease) including history of invasive opportunistic infections (e.g tuberculosis, histoplasmosis, listeriosis, coccidioidomycosis, pneumocystis, aspergillosis) despite infection resolution. Presence or suspicion of active bacterial, fungal or viral infections, or uncontrolled fever
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Biological | Level 1 - Ipilimumab (Anti-CTLA4): 2.5 mg, Level 2 - Ipilimumab 5 mg, Level 3 - Ipilimumab 10 mg |
Primary outcome
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jean-Marc JML LIMACHER, Dr study chair
Odimma Therapeutics
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Personalized cancer vaccine including : DNA neoantigen vaccine, MVA viral vector and Ipilimumab (anti-CTLA4) in people with Metastatic Colorectal Cancer (CRC) and Locally Advanced Colorectal Cancer, run by Centre Georges Francois Leclerc at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 22 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 14 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact François FG GHIRINGHELLI, Pr (03 45 34 75 38 ext. +33, fghiringhelli@cgfl.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2026.