Clinical trial • Phase I • Oncology
[177Lu]Lu-NNS309 for Colorectal cancer | Breast cancer | Non-small cell lung cancer | Pancreatic ductal adenocarcinoma
Phase I trial of [177Lu]Lu-NNS309 for Colorectal cancer | Breast cancer | Non-small cell lung cancer | Pancreatic ductal adenocarcinoma.
Overview
- Trial Therapeutic Area
- Oncology
- Trial Disease
- Colorectal cancer | Breast cancer | Non-small cell lung cancer | Pancreatic ductal adenocarcinoma
- Trial Stage
- Phase I
- Drug Modality
- Radiopharmaceutical
Key dates
- Initial CTIS Submission Date
- 21-08-2024
- First CTIS Authorization Date
- 04-12-2024
Trial design
open-label, none/not specified-controlled Phase I trial across 16 sites in Spain, Belgium, France and others.
- Open Label
- Yes
- Comparator
- None/Not specified
- Target Sample Size
- 48
Eligibility
Recruits 48 No vulnerable population selected; no special consent or assent handling mentioned..
- Vulnerable Population
- No vulnerable population selected; no special consent or assent handling mentioned.
Recruitment
- Planned Sample Size
- 48
- Recruitment Window Months
- 65
Geography
- Total Number Of Sites
- 16
- Total Number Of Participants
- 76
Spain
- Earliest CTIS Part Ii Submission Date
- 21-11-2024
- Latest Decision Or Authorization Date
- 17-04-2026
- Processing Time Days
- 512
- Number Of Sites
- 3
- Number Of Participants
- 21
Sites
- Site Name
- Hospital Universitario Fundacion Jimenez Diaz
- Department Name
- 1603 :Oncología
- Contact Person Name
- Bernard Gastón Doger de Speville
- Contact Person Email
- bernard.doger@startmadrid.com
- Site Name
- Hospital Clinic De Barcelona
- Department Name
- 1601 :Oncología
- Contact Person Name
- Iván Victoria Ruiz
- Contact Person Email
- IVICTORI@recerca.clinic.cat
- Site Name
- Hospital General Universitario Gregorio Maranon
- Department Name
- 1602 :Oncología
- Contact Person Name
- Aitana Calvo Ferrándiz
- Contact Person Email
- aitanacalvo@hotmail.com
Belgium
- Earliest CTIS Part Ii Submission Date
- 08-11-2024
- Latest Decision Or Authorization Date
- 15-04-2026
- Processing Time Days
- 523
- Number Of Sites
- 1
- Number Of Participants
- 7
Sites
- Site Name
- Institut Jules Bordet
- Department Name
- 1001:Nucleair Medicine
- Contact Person Name
- Patrick Flamen
- Contact Person Email
- Patrick.flamen@hubruxelles.be
France
- Earliest CTIS Part Ii Submission Date
- 27-09-2024
- Latest Decision Or Authorization Date
- 14-04-2026
- Processing Time Days
- 564
- Number Of Sites
- 4
- Number Of Participants
- 9
Sites
- Site Name
- Hospices Civils De Lyon
- Department Name
- 1102: Medecine Nucleaire
- Contact Person Name
- Anthime FLAUS
- Contact Person Email
- anthime.flaus@chu-lyon.fr
- Site Name
- Hospices Civils De Lyon
- Department Name
- 1102: Medecine Nucleaire
- Contact Person Name
- Anthime FLAUS
- Contact Person Email
- anthime.flaus@chu-lyon.fr
- Site Name
- Hospices Civils De Lyon
- Department Name
- 1102: Medecine Nucleaire
- Contact Person Name
- Anthime FLAUS
- Contact Person Email
- anthime.flaus@chu-lyon.fr
- Site Name
- Institut Gustave Roussy
- Department Name
- 1101: Medecine Nucleaire
- Contact Person Name
- Desiree DEANDREIS
- Contact Person Email
- Desiree.deandreis@gustaveroussy.fr
Italy
- Earliest CTIS Part Ii Submission Date
- 21-10-2024
- Latest Decision Or Authorization Date
- 15-04-2026
- Processing Time Days
- 541
- Number Of Sites
- 2
- Number Of Participants
- 7
Sites
- Site Name
- Azienda USL IRCCS Di Reggio Emilia
- Department Name
- 1402: S.C. Medicina Nucleare
- Contact Person Name
- Rexhep Durmo
- Contact Person Email
- Rexhep.durmo@ausl.re.it
- Site Name
- Fondazione IRCCS Istituto Nazionale Dei Tumori
- Department Name
- 1401: SC Medicina Nucleare
- Contact Person Name
- Marco Maccauro
- Contact Person Email
- marco.maccauro@istitutotumori.mi.it
Netherlands
- Earliest CTIS Part Ii Submission Date
- 03-12-2024
- Latest Decision Or Authorization Date
- 15-04-2026
- Processing Time Days
- 498
- Number Of Sites
- 2
- Number Of Participants
- 9
Sites
- Site Name
- Universitair Medisch Centrum Utrecht
- Department Name
- 1502 :Medische Oncologie
- Contact Person Name
- Cheryl Bruijnen
- Contact Person Email
- c.p.bruijnen@umcutrecht.nl
- Site Name
- Radboud universitair medisch centrum / RADBOUDUMC
- Department Name
- 1501 :Medische Beeldvorming, sectie Nucleaire Geneeskunde
- Contact Person Name
- Harm Westdorp
- Contact Person Email
- Harm.Westdorp@radboudumc.nl
Germany
- Earliest CTIS Part Ii Submission Date
- 18-10-2024
- Latest Decision Or Authorization Date
- 12-05-2026
- Processing Time Days
- 571
- Number Of Sites
- 4
- Number Of Participants
- 23
Sites
- Site Name
- Rostock University Medical Center
- Department Name
- 1204: Klinik und Poliklinik für Nuklearmedizin
- Contact Person Name
- Martin Heuschkel
- Contact Person Email
- martin.heuschkel@med.uni-rostock.de
- Site Name
- Klinikum rechts der Isar der TU Muenchen AöR
- Department Name
- 1202: Klinik und Poliklinik für Nuklearmedizin
- Contact Person Name
- Matthias Eiber
- Contact Person Email
- matthias.eiber@tum.de
- Site Name
- Universitaetsklinikum Essen AöR
- Department Name
- 1201: Klinik für Nuklearmedizin
- Contact Person Name
- Ken Herrmann
- Contact Person Email
- Ken.herrmann@uk-essen.de
- Site Name
- University Hospital Cologne AöR
- Department Name
- 1203: Klinik und Poliklinik für Nuklearmedizin
- Contact Person Name
- Alexander Drzezga
- Contact Person Email
- alexander.drzezga@uk-koeln.de
Sponsor
Primary sponsor
- Full Name
- Novartis Pharma AG
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- Switzerland
Investigational products
- Investigational Product Name
- [177Lu]Lu-NNS309
- Modality
- Radiopharmaceutical
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