Clinical trial • Phase I • Oncology

OT-A201 for Relapsed/refractory hematological malignancies | Advanced/metastatic solid tumors | Non-small cell lung cancer

Phase I trial of OT-A201 for Relapsed/refractory hematological malignancies | Advanced/metastatic solid tumors | Non-small cell lung cancer.

Overview

Trial Therapeutic Area
Oncology
Trial Disease
Relapsed/refractory hematological malignancies | Advanced/metastatic solid tumors | Non-small cell lung cancer
Trial Stage
Phase I

Key dates

Initial CTIS Submission Date
11-04-2024
First CTIS Authorization Date
14-06-2024

Trial design

Phase I trial across 13 sites in France.

Target Sample Size
239

Recruitment

Planned Sample Size
239
Recruitment Window Months
54

Geography

Total Number Of Sites
13
Total Number Of Participants
239

France

Earliest CTIS Part Ii Submission Date
17-04-2024
Latest Decision Or Authorization Date
29-04-2026
Processing Time Days
742
Number Of Sites
13
Number Of Participants
239

Sites

Site Name
Centre Hospitalier Regional De Marseille
Department Name
Centre d'Essais Précoces en Cancérologie (CEPCM)
Principal Investigator Name
Pascale TOMASINI
Principal Investigator Email
pascale.tomasini@ap-hm.fr
Contact Person Name
Pascale TOMASINI
Contact Person Email
pascale.tomasini@ap-hm.fr
Site Name
Institut Gustave Roussy
Department Name
Medical Oncology
Principal Investigator Name
Pernelle LAVAUD
Principal Investigator Email
Pernelle.lavaud@gustaveroussy.fr
Contact Person Name
Pernelle LAVAUD
Site Name
Gie Groupe Hospitalier Paris Saint-Joseph/Vinci
Department Name
Medical Oncology
Principal Investigator Name
Eric RAYMOND
Principal Investigator Email
eraymond@ghpsj.fr
Contact Person Name
Eric RAYMOND
Contact Person Email
eraymond@ghpsj.fr
Site Name
Institut Régional Cancer Montpellier - ICM Val d'Aurelle
Department Name
Early clinical trial Unit
Principal Investigator Name
Diego Tosi
Principal Investigator Email
diego.tosi@icm.unicancer.fr
Contact Person Name
Diego Tosi
Contact Person Email
diego.tosi@icm.unicancer.fr
Site Name
Centre Eugène Marquis
Department Name
Medical Oncology
Principal Investigator Name
Héloïse BOURIEN
Principal Investigator Email
h.bourien@rennes.unicancer.fr
Contact Person Name
Héloïse BOURIEN
Contact Person Email
h.bourien@rennes.unicancer.fr
Site Name
CHU Caen Normandie
Department Name
Institut d'Hématologie de Basse Normandie
Principal Investigator Name
Gandhi Laurent Damaj
Principal Investigator Email
damaj-gl@chu-caen.fr
Contact Person Name
Gandhi Laurent Damaj
Contact Person Email
damaj-gl@chu-caen.fr
Site Name
Centre Hospitalier Universitaire De Bordeaux
Department Name
Medical Oncology
Principal Investigator Name
Charlotte DOMBLIDES
Principal Investigator Email
charlotte.domblides@chu-bordeaux.fr
Contact Person Name
Charlotte DOMBLIDES
Site Name
Hopital Henri Mondor - 1 rue Gustave Eiffel
Department Name
Unité Hémopathies Lymphoïdes & INSERMU955
Principal Investigator Name
François Lemonnier
Principal Investigator Email
francois.lemonnier@aphp.fr
Contact Person Name
François Lemonnier
Contact Person Email
francois.lemonnier@aphp.fr
Site Name
Oncopole Claudius Regaud
Department Name
Medical oncology - Early Phase Unit
Principal Investigator Name
Pierre BORIES
Principal Investigator Email
bories.pierre@iuct-oncopole.fr
Contact Person Name
Pierre BORIES
Contact Person Email
bories.pierre@iuct-oncopole.fr
Site Name
Assistance Publique Hopitaux De Paris
Department Name
Département Hématologie Clinique et Thérapie cellulaire
Principal Investigator Name
Mohamad MOHTY
Principal Investigator Email
mohamad.mohty@aphp.fr
Contact Person Name
Mohamad MOHTY
Contact Person Email
mohamad.mohty@aphp.fr
Site Name
CHRU Nancy Brabois
Department Name
Hematology
Principal Investigator Name
Pierre Feugier
Principal Investigator Email
p.feugier@chru-nancy.fr
Contact Person Name
Pierre Feugier
Contact Person Email
p.feugier@chru-nancy.fr
Site Name
Centre Hospitalier Universitaire De Lille
Department Name
Service des Maladies du Sang
Principal Investigator Name
Salomon Manier
Principal Investigator Email
SALOMON.MANIER@chu-lille.fr
Contact Person Name
Salomon Manier
Contact Person Email
SALOMON.MANIER@chu-lille.fr
Site Name
Centre Hospitalier Universitaire De Montpellier
Department Name
Hematology
Principal Investigator Name
Guillaume CARTRON
Principal Investigator Email
g-cartron@chu-montpellier.fr
Contact Person Name
Guillaume CARTRON
Contact Person Email
g-cartron@chu-montpellier.fr

Sponsor

Primary sponsor

Full Name
Onward Therapeutics France
Organisation Type
Pharmaceutical company
Country Of Registered Address
France

Investigational products

Investigational Product Name
OT-A201
First In Human
Yes

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