Clinical trial • Phase I • Oncology|Gastroenterology

ODI-2001 vaccine for Pancreatic cancer (metastatic or locally advanced)|Colorectal cancer (metastatic or locally advanced)

Phase I trial of ODI-2001 vaccine for Pancreatic cancer (metastatic or locally advanced)|Colorectal cancer (metastatic or locally advanced).

Overview

Trial Therapeutic Area
Oncology|Gastroenterology
Trial Disease
Pancreatic cancer (metastatic or locally advanced)|Colorectal cancer (metastatic or locally advanced)
Trial Stage
Phase I
Drug Modality
Vaccine

Key dates

Initial CTIS Submission Date
26-08-2025
First CTIS Authorization Date
10-02-2026

Trial design

open-label, adaptive Phase I trial across 2 sites in France.

Open Label
Yes
Adaptive
Yes
Single Multiple Or Escalation Dose Combined
Yes
Target Sample Size
83

Recruitment

Planned Sample Size
83
Recruitment Window Months
89

Geography

Total Number Of Sites
2
Total Number Of Participants
83

France

Earliest CTIS Part Ii Submission Date
02-12-2025
Latest Decision Or Authorization Date
10-02-2026
Processing Time Days
70
Number Of Sites
2
Number Of Participants
83

Sites

Site Name
Centr Georges Francois Leclerc
Department Name
Oncology
Principal Investigator Name
François GHIRINGHELLI
Principal Investigator Email
fghiringhelli@cgfl.fr
Contact Person Name
François GHIRINGHELLI
Contact Person Email
fghiringhelli@cgfl.fr
Site Name
CHRU Jean Minjoz
Department Name
Oncology
Principal Investigator Name
Christophe BORG
Principal Investigator Email
Xtophe.borg@gmail.com
Contact Person Name
Christophe BORG
Contact Person Email
Xtophe.borg@gmail.com

Sponsor

Primary sponsor

Full Name
Centr Georges Francois Leclerc
Organisation Type
Hospital/Clinic/Other health care facility
Country Of Registered Address
France

Investigational products

Investigational Product Name
ODI-2001 vaccine
Modality
Vaccine

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