Clinical trial • Phase I • Oncology
ASP5834 for Advanced (unresectable) or metastatic solid tumours harbouring KRAS mutation or KRAS amplification
Phase I trial of ASP5834 for Advanced (unresectable) or metastatic solid tumours harbouring KRAS mutation or KRAS amplification. 294 participants.
Overview
- Trial Therapeutic Area
- Oncology
- Trial Disease
- Advanced (unresectable) or metastatic solid tumours harbouring KRAS mutation or KRAS amplification
- Trial Stage
- Phase I
Key dates
- Initial CTIS Submission Date
- 18-08-2025
- First CTIS Authorization Date
- 28-11-2025
Trial design
Phase I trial in France, Spain.
- Single Multiple Or Escalation Dose Combined
- Yes
- Target Sample Size
- 294
Eligibility
Recruits 294 Vulnerable population selected (isVulnerablePopulationSelected: true). No details on consent, assent or special handling of vulnerable participants are provided in the available source..
- Vulnerable Population
- Vulnerable population selected (isVulnerablePopulationSelected: true). No details on consent, assent or special handling of vulnerable participants are provided in the available source.
Recruitment
- Planned Sample Size
- 294
- Recruitment Window Months
- 38
- Consent Approach
- Not specified. No details on informed consent, assent process, who provides consent, age-specific documents, or languages available are provided in the source.
Geography
- Total Number Of Sites
- 7
- Total Number Of Participants
- 70
France
- Earliest CTIS Part Ii Submission Date
- 16-10-2025
- Latest Decision Or Authorization Date
- 31-03-2026
- Processing Time Days
- 166
- Number Of Sites
- 4
- Number Of Participants
- 40
Sites
- Site Name
- Hospices Civils De Lyon
- Department Name
- Medical Oncology
- Contact Person Name
- Benoit You
- Contact Person Email
- benoit.you@chu-lyon.fr
- Site Name
- Institut Gustave Roussy
- Department Name
- Medicine
- Contact Person Name
- Fabrice Barlesi
- Contact Person Email
- Fabrice.Barlesi@gustaveroussy.fr
- Site Name
- Institut Bergonie
- Department Name
- Medical Oncology
- Contact Person Name
- Véronique Debien
- Contact Person Email
- v.debien@bordeaux.unicancer.fr
- Site Name
- Centre Leon Berard
- Department Name
- Medical Oncology
- Contact Person Name
- Philippe Casier
- Contact Person Email
- philippe.cassier@lyon.unicancer.fr
Spain
- Earliest CTIS Part Ii Submission Date
- 07-11-2025
- Latest Decision Or Authorization Date
- 13-04-2026
- Processing Time Days
- 157
- Number Of Sites
- 3
- Number Of Participants
- 30
Sites
- Site Name
- Hospital Universitario 12 De Octubre
- Department Name
- Medical Oncology
- Contact Person Name
- Santiago Ponce Aix
- Contact Person Email
- santiago.ponce@oncosur.org
- Site Name
- Hospital Universitario Fundacion Jimenez Diaz
- Department Name
- Oncology
- Contact Person Name
- Victor Moreno Garcia
- Contact Person Email
- victor.moreno@startmadrid.com
- Site Name
- Hospital Universitari Vall D Hebron
- Department Name
- Medical Oncology
- Contact Person Name
- Jaume Capdevila Castellon
- Contact Person Email
- jcapdevila@vhio.net
Sponsor
Primary sponsor
- Full Name
- Astellas Pharma Inc.
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- Japan
Investigational products
- Investigational Product Name
- ASP5834
Related trials
Other published trials that may interest you.
- GDC-9545 for Locally advanced or metastatic estrogen receptor-positive breast cancer
- Abemaciclib for Stage IV lung cancer | Breast cancer
- BGB-43395 for Advanced or metastatic solid tumors | Hormone receptor positive HER2 negative breast cancer
- AZD9833 for Estrogen receptor-positive HER2-negative advanced breast cancer
- Pembrolizumab for Classical Hodgkin lymphoma | Melanoma | Solid tumours (MSI-H/dMMR) | Solid tumours (TMB-H)