Clinical trial • Phase I | Phase III • Oncology
eftilagimod alpha for Non-small cell lung cancer | Urothelial carcinoma | Peritoneal carcinomatosis | Malignant solid tumor
Phase I | Phase III trial of eftilagimod alpha for Non-small cell lung cancer | Urothelial carcinoma | Peritoneal carcinomatosis | Malignant solid tumor.
Overview
- Trial Therapeutic Area
- Oncology
- Trial Disease
- Non-small cell lung cancer | Urothelial carcinoma | Peritoneal carcinomatosis | Malignant solid tumor
- Trial Stage
- Phase I | Phase III
- Drug Modality
- Peptide/protein/enzyme
Key dates
- Initial CTIS Submission Date
- 26-09-2024
- First CTIS Authorization Date
- 23-10-2024
Trial design
open-label Phase I | Phase III trial across 14 sites in Germany.
- Open Label
- Yes
- Target Sample Size
- 110
Eligibility
Recruits 110 Vulnerable population selected (isVulnerablePopulationSelected = true) in CTIS metadata; no further details on consent, assent or age-specific consent documents provided in the available record..
- Vulnerable Population
- Vulnerable population selected (isVulnerablePopulationSelected = true) in CTIS metadata; no further details on consent, assent or age-specific consent documents provided in the available record.
Recruitment
- Planned Sample Size
- 110
- Recruitment Window Months
- 108
Geography
- Total Number Of Sites
- 14
- Total Number Of Participants
- 110
Germany
- Earliest CTIS Part Ii Submission Date
- 07-10-2024
- Latest Decision Or Authorization Date
- 15-04-2026
- Processing Time Days
- 555
- Number Of Sites
- 14
- Number Of Participants
- 110
Sites
- Site Name
- Agaplesion Frankfurter Diakonie Kliniken gGmbH
- Department Name
- Agaplesion Markus Krankenhaus
- Contact Person Name
- Silvan Becker
- Contact Person Email
- silvan.becker@agaplesion.de
- Site Name
- Krankenhaus Nordwest GmbH
- Department Name
- IKF
- Contact Person Name
- Thorsten Götze
- Contact Person Email
- Goetze.Thorsten@KHNW.DE
- Site Name
- Universitaetsklinikum Tuebingen AöR
- Department Name
- Klinik für Urologie
- Contact Person Name
- Igor Tsaur
- Contact Person Email
- igor.tsaur@med.uni-tuebingen.de
- Site Name
- HELIOS Klinikum Bad Saarow GmbH
- Department Name
- Klinik für Onkologie und Palliativmedizin
- Contact Person Name
- Daniel Pink
- Contact Person Email
- daniel.pink@helios-gesundheit.de
- Site Name
- Universitaetsklinikum Giessen und Marburg GmbH
- Department Name
- Standort Gießen, Medizinische Klinik IV
- Contact Person Name
- Bastian Eul
- Contact Person Email
- Bastian.Eul@innere.med.uni-giessen.de
- Site Name
- Hämatologisch Onkologische Praxis Eppendorf (HOPE)
- Department Name
- Norddeutsches Studienzentrum für Innovative Onkologie (NIO)
- Contact Person Name
- Eray Gökkurt
- Contact Person Email
- goekkurt@onkologie-eppendorf.de
- Site Name
- Universitaetsklinikum Frankfurt AöR
- Department Name
- Medizinische Klinik II Hämatologie/ Onkologie, Rheumatologie, Infektiologie, HIV
- Contact Person Name
- Martin Sebastian
- Contact Person Email
- sebastian@med.uni-frankfurt.de
- Site Name
- Universitaetsklinikum Ulm AöR
- Department Name
- Early Clinical Trials Unit (ECTU) Comprehensive Cancer Center
- Contact Person Name
- Friedemann Zengerling
- Contact Person Email
- Friedemann.Zengerling@uniklinik-ulm.de
- Site Name
- HELIOS Dr. Horst Schmidt Kliniken Wiesbaden GmbH
- Department Name
- Inn. Med. III, Hämatologie, Onkologie, Palliativmedizin
- Contact Person Name
- Wolfgang Blau
- Contact Person Email
- wolfgang.blau@helios-gesundheit.de
- Site Name
- Klinikum Frankfurt Hoechst GmbH
- Contact Person Name
- Hans-Günter Derigs
- Contact Person Email
- hans.derigs@varisano.de
- Site Name
- Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöR
- Department Name
- III. Medizinische Klinik und Poliklinik Hämatologie und Medizinische Onkologie
- Contact Person Name
- Jürgen Alt
- Contact Person Email
- Juergen.Alt@unimedizin-mainz.de
- Site Name
- Kliniken der Stadt Koeln gGmbH
- Department Name
- Studienzentrum der Lungenklinik/ Krankenhaus Merheim
- Contact Person Name
- Carolin Groß-Ophoff-Müller
- Contact Person Email
- GrossOphoffMuellerC@kliniken-koeln.de
- Site Name
- St. Elisabeth Gruppe GmbH Katholische Kliniken Rhein-Ruhr
- Department Name
- Klinik für Urologie
- Contact Person Name
- Florian Roghmann
- Contact Person Email
- Florian.Roghmann@elisabethgruppe.de
- Site Name
- Universitaetsklinikum Essen AöR
- Department Name
- Klinik und Poliklinik für Urologie, Kinderurologie und Uroonkologie
- Contact Person Name
- Viktor Grünwald
- Contact Person Email
- Viktor.Gruenwald@uk-essen.de
Sponsor
Primary sponsor
- Full Name
- Frankfurter Institut Fuer Klinische Krebsforschung IKF GmbH
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- Germany
Investigational products
- Investigational Product Name
- eftilagimod alpha (IMP321)
- Active Substance
- eftilagimod alpha
- Modality
- Peptide/protein/enzyme
- Combination Treatment
- Yes
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