Clinical trial • Phase I • Oncology
ARV-806 for KRAS G12D-mutated advanced solid tumors
Phase I trial of ARV-806 for KRAS G12D-mutated advanced solid tumors. 98 participants.
Overview
- Trial Therapeutic Area
- Oncology
- Trial Disease
- KRAS G12D-mutated advanced solid tumors
- Trial Stage
- Phase I
Key dates
- Initial CTIS Submission Date
- 30-10-2025
- First CTIS Authorization Date
- 12-03-2026
Trial design
Phase I trial across 6 sites in Italy, Spain.
- Biomarker Stratified
- True, biomarker: KRAS G12D mutation
- Target Sample Size
- 98
Eligibility
Recruits 98 Vulnerable populations not selected; trial population limited to adults. Consent/assent handling not described in available documents..
- Vulnerable Population
- Vulnerable populations not selected; trial population limited to adults. Consent/assent handling not described in available documents.
Recruitment
- Planned Sample Size
- 98
- Recruitment Window Months
- 35
Geography
- Total Number Of Sites
- 6
- Total Number Of Participants
- 51
Italy
- Earliest CTIS Part Ii Submission Date
- 25-02-2026
- Latest Decision Or Authorization Date
- 12-03-2026
- Processing Time Days
- 15
- Number Of Sites
- 2
- Number Of Participants
- 14
Sites
- Site Name
- Centro Ricerche Cliniche Di Verona S.r.l.
- Department Name
- UOS di Terapie Sperimentali in Oncologia
- Principal Investigator Name
- Davide Melisi
- Principal Investigator Email
- davide.melisi@univr.it
- Contact Person Name
- Davide Melisi
- Contact Person Email
- davide.melisi@univr.it
- Site Name
- Azienda Ospedaliero Universitaria Pisana
- Department Name
- UO Oncologia Medica 2
- Principal Investigator Name
- Chiara Cremolini
- Principal Investigator Email
- chiaracremolini@gmail.com
- Contact Person Name
- Chiara Cremolini
- Contact Person Email
- chiaracremolini@gmail.com
Spain
- Earliest CTIS Part Ii Submission Date
- 19-12-2025
- Latest Decision Or Authorization Date
- 16-03-2026
- Processing Time Days
- 87
- Number Of Sites
- 4
- Number Of Participants
- 37
Sites
- Site Name
- Hospital Universitario Fundacion Jimenez Diaz
- Department Name
- Oncology
- Principal Investigator Name
- Victor Moreno García
- Principal Investigator Email
- victor.moreno@startmadrid.com
- Contact Person Name
- Victor Moreno García
- Contact Person Email
- victor.moreno@startmadrid.com
- Site Name
- Clinica Universidad De Navarra
- Department Name
- Medical Oncology
- Principal Investigator Name
- Mariano Ponz Sarvise
- Principal Investigator Email
- mponz@unav.es
- Contact Person Name
- Mariano Ponz Sarvise
- Contact Person Email
- mponz@unav.es
- Site Name
- Hospital Clinico Universitario De Valencia
- Department Name
- Medical Oncology, Phase I Unit
- Principal Investigator Name
- Valentina Gambardella
- Principal Investigator Email
- valen.gambardella@gmail.com
- Contact Person Name
- Valentina Gambardella
- Contact Person Email
- valen.gambardella@gmail.com
- Site Name
- Hospital Universitari Vall D Hebron
- Department Name
- Medical Oncology
- Principal Investigator Name
- Elena Garralda Cabanas
- Principal Investigator Email
- egarralda@vhio.net
- Contact Person Name
- Elena Garralda Cabanas
- Contact Person Email
- egarralda@vhio.net
Sponsor
Primary sponsor
- Full Name
- Arvinas Operations Inc.
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- United States
Investigational products
- Investigational Product Name
- ARV-806
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