Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Authorised, recruitment pending
Participants planned
149
Countries
2
Sites
6
KRAS G12D Mutated Advanced Solid Tumors
Key facts
- Sponsor
- Arvinas Operations Inc.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Decision date (initial)
- 2026-03-12
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2025-521062-10-00
- ClinicalTrials.gov
- NCT07023731
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
KRAS G12D Mutated Advanced Solid Tumors
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 28.0 | LLT | 10069759 | KRAS mutation | 10018065 |
| 21.1 | LLT | 10065252 | Solid tumor | 10029104 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Arvinas Operations Inc.
- Sponsor organisation
- Arvinas Operations Inc.
- Address
- 5 Science Park
- City
- New Haven
- Postcode
- 06511-1966
- Country
- United States
Scientific contact point
- Organisation
- Arvinas Operations Inc.
- Contact name
- Executive Medical Director, Clinical Development - Oncology
Public contact point
- Organisation
- Arvinas Operations Inc.
- Contact name
- Senior Vice President, Global Regulatory Affairs
Locations
2 EU/EEA countries · 6 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Italy | Authorised, recruitment pending | 14 | 2 |
| Spain | Authorised, recruitment pending | 37 | 4 |
| Rest of world
United States
|
— | 98 | — |
Investigational sites
Centro Ricerche Cliniche Di Verona S.r.l.
UOS di Terapie Sperimentali in Oncologia, Piazzale Ludovico Antonio Scuro 10, 37134, Verona
Azienda Ospedaliero Universitaria Pisana
UO Oncologia Medica 2, Via Roma 67, 56126, Pisa
Hospital Universitario Fundacion Jimenez Diaz
Oncology, Avenida De Los Reyes Catolicos 2, 28040, Madrid
Clinica Universidad De Navarra
Medical Oncology, Pio XII Etorbidea 36, 31008, Pamplona
Hospital Clinico Universitario De Valencia
Medical Oncology, Phase I Unit, Avenida Blasco Ibanez 17, 46010, Valencia
Hospital Universitari Vall D Hebron
Medical Oncology, Passeig De La Vall D'Hebron 119-129, 08035, Barcelona
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-10-30 | Italy | Acceptable 2026-03-09
|
2026-03-12 |