Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Authorised, recruiting
Participants planned
429
Countries
7
Sites
14
KRAS Altered Advanced or Metastatic Solid Tumors
Key facts
- Sponsor
- Amgen Inc.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 26 Nov 2025 → ongoing
- Decision date (initial)
- 2025-10-28
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
KRAS Altered Advanced or Metastatic Solid Tumors
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.0 | PT | 10061451 | Colorectal cancer | 100000004864 |
| 28.0 | SOC | 10029104 | Neoplasms benign malignant and unspecified (incl cysts and polyps) | 2 |
| 20.0 | PT | 10073364 | Ductal adenocarcinoma of pancreas | 100000004864 |
| 27.1 | PT | 10061873 | Non-small cell lung cancer | 100000004864 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Amgen Inc.
- Sponsor organisation
- Amgen Inc.
- Address
- 1 Amgen Center Drive
- City
- Thousand Oaks
- Postcode
- 91320-1730
- Country
- United States
Scientific contact point
- Organisation
- Amgen Inc.
- Contact name
- Medical Information
Public contact point
- Organisation
- Amgen Inc.
- Contact name
- Medical Information
Locations
7 EU/EEA countries · 14 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Belgium | Ongoing, recruiting | 20 | 2 |
| Denmark | Authorised, recruiting | 8 | 1 |
| France | Ongoing, recruiting | 30 | 3 |
| Germany | Ongoing, recruiting | 14 | 1 |
| Italy | Ongoing, recruiting | 23 | 3 |
| Netherlands | Ongoing, recruiting | 10 | 1 |
| Spain | Ongoing, recruiting | 30 | 3 |
| Rest of world
United States, Korea, Republic of, Australia, Japan, United Kingdom, China, Canada
|
— | 294 | — |
Investigational sites
Universitair Ziekenhuis Gent
Oncology, Corneel Heymanslaan 10, 9000, Gent
Universitair Ziekenhuis Antwerpen
Oncology, Drie Eikenstraat 655, 2650, Edegem
Rigshospitalet
Department of Oncology, Blegdamsvej 9, 2100, Copenhagen Oe
Institut Gustave Roussy
DITEP Drug Development Department, 114 Rue Edouard Vaillant, 94800, Villejuif
Centre Leon Berard
Medical Oncology, 28 Rue Laennec, 69008, Lyon
Centre Oscar Lambret
Medical oncology department, 3 Rue Frederic Combemale, 59000, Lille
Universitaetsklinikum Essen AöR
Innere Klinik (Tumorforschung), Hufelandstrasse 55, Holsterhausen, Essen
Azienda Ospedaliero Universitaria Pisana
Oncologia, Via Roma 67, 56126, Pisa
Centro Ricerche Cliniche Di Verona S.r.l.
Oncologia, Piazzale Ludovico Antonio Scuro 10, 37134, Verona
ASST Grande Ospedale Metropolitano Niguarda
Ematologia e Oncologia, Piazza Dell'ospedale Maggiore 3, 20162, Milan
Universitair Medisch Centrum Utrecht
Medische Oncologie, Heidelberglaan 100, 3584 CX, Utrecht
Hospital Universitario Fundacion Jimenez Diaz
Servicio de Oncología, Avenida De Los Reyes Catolicos 2, 28040, Madrid
Hospital Universitari Vall D Hebron
Servicio de Oncología, Passeig De La Vall D'Hebron 119-129, 08035, Barcelona
Hospital Universitario 12 De Octubre
Servicio de Oncología, Avenida De Cordoba Sn, 28041, Madrid
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 |
|---|---|---|---|---|---|
| Belgium | 2025-12-10 | 2026-05-06 | |||
| Denmark | 2026-01-29 | ||||
| France | 2025-12-02 | 2025-12-05 | |||
| Germany | 2025-11-26 | 2026-01-22 | |||
| Italy | 2025-12-05 | 2026-01-16 | |||
| Netherlands | 2025-12-22 | 2026-02-20 | |||
| Spain | 2025-12-10 | 2026-04-07 |
Application history
3 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-07-08 | Denmark | Acceptable 2025-10-27
|
2025-10-28 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2026-01-16 | Acceptable | 2026-02-02 | |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2026-02-10 | Denmark | Acceptable 2026-04-28
|
2026-04-28 |