Clinical trial • Phase I • Oncology
Clinical trial in KRAS G12D-mutant solid tumors
Phase I trial for KRAS G12D-mutant solid tumors. 440 participants.
Overview
- Trial Therapeutic Area
- Oncology
- Trial Disease
- KRAS G12D-mutant solid tumors
- Trial Stage
- Phase I
Key dates
- Initial CTIS Submission Date
- 13-09-2024
- First CTIS Authorization Date
- 20-01-2025
Trial design
Phase I trial across 12 sites in Germany, Ireland, Spain and others.
- Target Sample Size
- 440
Eligibility
Recruits 440 Vulnerable population selected (isVulnerablePopulationSelected: true). No further details on consent or assent handling are provided in the available record..
- Vulnerable Population
- Vulnerable population selected (isVulnerablePopulationSelected: true). No further details on consent or assent handling are provided in the available record.
Recruitment
- Planned Sample Size
- 440
- Recruitment Window Months
- 35
- Consent Approach
- Not specified. No informed consent or assent process details provided in the available record.
Geography
- Total Number Of Sites
- 12
- Total Number Of Participants
- 190
Germany
- Earliest CTIS Part Ii Submission Date
- 17-12-2024
- Latest Decision Or Authorization Date
- 03-03-2026
- Processing Time Days
- 441
- Number Of Sites
- 4
- Number Of Participants
- 55
Sites
- Site Name
- Klinikum der Universitaet Muenchen AöR
- Department Name
- Medizinische Klinik und Poliklinik III
- Contact Person Name
- Lena Weiss
- Contact Person Email
- Lena.Weiss@med.lmu.de
- Site Name
- Technische Universitaet Dresden
- Department Name
- Nationales Centrum für Tumorerkrankungen Dresden, Early Clinical Trial Unit (NCT/UCC ECTU)
- Contact Person Name
- Martin Wermke
- Contact Person Email
- Martin.Wermke@uniklinikum-dresden.de
- Site Name
- Charite Universitaetsmedizin Berlin KöR
- Department Name
- Medizinische Klinik mit Schwerpunkt Hämatologie, Onkologie und Tumorimmunologie (CVK)
- Contact Person Name
- Dominik Modest
- Contact Person Email
- dominik.modest@charite.de
- Site Name
- Universitaetsklinikum Essen AöR
- Department Name
- Innere Klinik (Tumorforschung)
- Contact Person Name
- Martin Schuler
- Contact Person Email
- Martin.Schuler@uk-essen.de
Ireland
- Earliest CTIS Part Ii Submission Date
- 16-12-2024
- Latest Decision Or Authorization Date
- 02-03-2026
- Processing Time Days
- 441
- Number Of Sites
- 1
- Number Of Participants
- 25
Sites
- Site Name
- Mater Misericordiae University Hospital
- Department Name
- Oncology
- Contact Person Name
- Austin Duffy
- Contact Person Email
- austin.duffy@startdublin.com
Spain
- Earliest CTIS Part Ii Submission Date
- 07-01-2025
- Latest Decision Or Authorization Date
- 09-03-2026
- Processing Time Days
- 426
- Number Of Sites
- 4
- Number Of Participants
- 55
Sites
- Site Name
- Hospital Universitario 12 De Octubre
- Department Name
- Oncology
- Contact Person Name
- Rocio Garcia Carbonero
- Contact Person Email
- rgcarbonero@gmail.com
- Site Name
- Hospital Hm Nou Delfos
- Department Name
- Oncology
- Contact Person Name
- Tatiana Hernandez Guerrero
- Contact Person Email
- Tatiana.hernandez@start-barcelona.com
- Site Name
- Hospital Universitari Vall D Hebron
- Department Name
- Oncology
- Contact Person Name
- Elena Garralda Cabanas
- Contact Person Email
- egarralda@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
Italy
- Earliest CTIS Part Ii Submission Date
- 19-12-2024
- Latest Decision Or Authorization Date
- 04-03-2026
- Processing Time Days
- 440
- Number Of Sites
- 3
- Number Of Participants
- 55
Sites
- Site Name
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Department Name
- UOC Fase I (Unità di Farmacologia Clinica)
- Contact Person Name
- Gennaro Daniele
- Contact Person Email
- gennaro.daniele@policlinicogemelli.it
- Site Name
- Centro Ricerche Cliniche Di Verona S.r.l.
- Department Name
- Centro Ricerche Cliniche di Verona srl
- Contact Person Name
- Davide Melisi
- Contact Person Email
- davide.melisi@univr.it
- Site Name
- Azienda Ospedaliera Universitaria Universita' Degli Studi Della Campania Luigi Vanvitelli
- Department Name
- UOC Oncoematologia AOU Vanvitelli
- Contact Person Name
- Erika Martinelli
- Contact Person Email
- erika.martinelli@unicampania.it
Sponsor
Primary sponsor
- Full Name
- Eli Lilly & Co.
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- United States
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