Clinical trial • Phase I • Oncology|Gastroenterology

CEACAM5 x CD3 antibody for Locally advanced or metastatic colorectal cancer (low tumor volume)

Phase I trial of CEACAM5 x CD3 antibody for Locally advanced or metastatic colorectal cancer (low tumor volume). 12 participants.

Overview

Trial Therapeutic Area
Oncology|Gastroenterology
Trial Disease
Locally advanced or metastatic colorectal cancer (low tumor volume)
Trial Stage
Phase I
Drug Modality
Bispecific antibody

Key dates

Initial CTIS Submission Date
29-09-2023
First CTIS Authorization Date
19-01-2024

Trial design

Phase I trial across 2 sites in Spain.

Target Sample Size
12

Recruitment

Planned Sample Size
12
Recruitment Window Months
39

Geography

Total Number Of Sites
2
Total Number Of Participants
12

Spain

Earliest CTIS Part Ii Submission Date
13-10-2023
Latest Decision Or Authorization Date
19-01-2024
Processing Time Days
98
Number Of Sites
2
Number Of Participants
12

Sites

Site Name
Vall D'hebron Institut De Recerca
Department Name
Oncology
Contact Person Name
Iosune Baraibar Argota
Contact Person Email
ibaraibar@vhio.net
Site Name
Hospital Universitario Fundacion Jimenez Diaz
Department Name
Oncology
Contact Person Name
Victor Moreno Garcia
Contact Person Email
victor.moreno@startmadrid.com

Sponsor

Primary sponsor

Full Name
NovImmune S.A.
Organisation Type
Pharmaceutical company
Country Of Registered Address
Switzerland

Investigational products

Investigational Product Name
NILK-2301
Active Substance
CEACAM5 x CD3 antibody
Modality
Bispecific antibody
Authorisation Status
Not authorised

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