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
- Contact Person Email
- Pernelle.lavaud@gustaveroussy.fr
- 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
- Contact Person Email
- charlotte.domblides@chu-bordeaux.fr
- 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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