Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ongoing, recruiting
Participants planned
364
Countries
2
Sites
7
Locally advanced (unresectable) or metastatic solid tumor malignancies who harbor a KRAS mutation (G12V, G12D, G12C, G12A, G12R or G13D mutation) or KRAS amplification
Key facts
- Sponsor
- Astellas Pharma Inc.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 16 Jan 2026 → ongoing
- Decision date (initial)
- 2025-11-28
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2025-522082-29-00
- ClinicalTrials.gov
- NCT07094204
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Locally advanced (unresectable) or metastatic solid tumor malignancies who harbor a KRAS mutation (G12V, G12D, G12C, G12A, G12R or G13D mutation) or KRAS amplification
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Astellas Pharma Inc.
- Sponsor organisation
- Astellas Pharma Inc.
- Address
- 2-5-1, Nihonbashi-Honcho Nihonbashi-Honcho
- City
- Chuo-Ku
- Postcode
- 103-8411
- Country
- Japan
Scientific contact point
- Organisation
- Astellas Pharma Inc.
- Contact name
- Head of Clinical Trial Unit Regulatory Affairs
Public contact point
- Organisation
- Astellas Pharma Inc.
- Contact name
- Head of Clinical Trial Unit Regulatory Affairs
Locations
2 EU/EEA countries · 7 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Ongoing, recruiting | 40 | 4 |
| Spain | Ongoing, recruiting | 30 | 3 |
| Rest of world
Korea, Republic of, United States, Japan
|
— | 294 | — |
Investigational sites
Hospices Civils De Lyon
Medical Oncology, 165 Chemin Du Grand Revoyet, 69310, Pierre Benite
Institut Gustave Roussy
Medicine, 114 Rue Edouard Vaillant, 94800, Villejuif
Institut Bergonie
Medical Oncology, 180 R De Saint Genes, 229 Cours De L Argonne, Bordeaux
Centre Leon Berard
Medical Oncology, 28 Rue Laennec, 69008, Lyon
Hospital Universitario Fundacion Jimenez Diaz
Oncology, Avenida De Los Reyes Catolicos 2, 28040, Madrid
Hospital Universitario 12 De Octubre
Medical Oncology, Avenida De Cordoba Sn, 28041, Madrid
Hospital Universitari Vall D Hebron
Medical Oncology, Passeig De La Vall D'Hebron 119-129, 08035, Barcelona
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| France | 2026-01-21 | 2026-01-21 | |||
| Spain | 2026-01-16 | 2026-01-16 |
Application history
4 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-08-18 | Spain | Acceptable with conditions 2025-11-28
|
2025-11-28 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2026-02-20 | Spain | Acceptable 2026-03-27
|
2026-03-31 |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2026-04-15 | Spain | Acceptable 2026-03-27
|
2026-04-15 |
| 4 | SUBSTANTIAL MODIFICATION | SM-2 | 2026-05-12 | Acceptable | 2026-05-27 |