Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Authorised, recruitment pending
Participants planned
464
Countries
3
Sites
22
microsatellite instability high/mismatch repair deficient (MSI-H/dMMR) 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]
- Decision date (initial)
- 2026-04-29
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2025-524056-63-00
- WHO UTN
- U1111-1331-5166
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
microsatellite instability high/mismatch repair deficient (MSI-H/dMMR) solid tumors
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.1 | LLT | 10079619 | MSI-high | 10029104 |
| 27.1 | PT | 10061289 | Metastatic neoplasm | 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
3 EU/EEA countries · 22 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Belgium | Authorised, recruitment pending | 17 | 4 |
| France | Authorised, recruitment pending | 30 | 8 |
| Spain | Authorised, recruitment pending | 30 | 10 |
| Rest of world
United States, China, Korea, Republic of, Canada, Australia, Japan, Brazil, Taiwan
|
— | 387 | — |
Investigational sites
Cliniques Universitaires Saint-Luc
Oncology, Hippokrateslaan 10, Batiment 54, Sint-Lambrechts-Woluwe
UZ Leuven
Digestive Oncology, Herestraat 49, 3000, Leuven
Universitair Ziekenhuis Gent
Medical Oncology, Corneel Heymanslaan 10, 9000, Gent
Universitair Ziekenhuis Antwerpen
Oncology, Drie Eikenstraat 655, 2650, Edegem
Centre Oscar Lambret
Medical Oncology - Gastroenterology and Urology, 3 Rue Frederic Combemale, 59000, Lille
Assistance Publique Hopitaux De Paris
Medical Oncology, 20 Rue Leblanc, 75015, Paris
Centre Leon Berard
Medical Oncology, 28 Rue Laennec, 69008, Lyon
Institut Gustave Roussy
DITEP, 114 Rue Edouard Vaillant, 94800, Villejuif
Hopital Saint Antoine
Oncology, 184 Rue Du Faubourg Saint Antoine, 75571, Paris Cedex 12
Hospices Civils De Lyon
Medical Oncology, 165 Chemin Du Grand Revoyet, 69310, Pierre Benite
Centr Georges Francois Leclerc
Medical Oncology, 1 Rue Professeur Marion, 21000, Dijon
Institut Paoli Calmettes
Oncology, 232 Boulevard De Sainte Marguerite, Bp 156, Marseille
Complexo Hospitalario Universitario A Coruna
Servicio de Oncologia Medica, Lugar Jubias De Arriba 84, 15006, A Coruna
Hospital Clinic De Barcelona
Servicio de Oncologia Medica, Calle Villarroel 170, 08036, Barcelona
Hospital Clinico Universitario De Valencia
Servicio de Hematologia y Oncologia, Avenida Blasco Ibanez 17, 46010, Valencia
Hospital Universitario Virgen De Las Nieves
Servicio de Oncologia Medica, Avenida De Las Fuerzas Armadas 2, 18014, Granada
Hospital Universitario Virgen De La Victoria
Servicio de Oncologia, Campus De Teatinos Sn, Puerto De La Torre, Malaga
Hospital General Universitario Gregorio Maranon
Servicio de Oncologia Medica, Calle Del Doctor Esquerdo 46, 28009, Madrid
Hospital Universitari Vall D Hebron
Servicio de Oncologia, Passeig De La Vall D'Hebron 119-129, 08035, Barcelona
Hospital Universitario Marques De Valdecilla
Servicio de Oncologia Medica, Avenida Valdecilla Sn, 39008, Santander
Hospital Universitario 12 De Octubre
Servicio de Oncologia, Avenida De Cordoba Sn, 28041, Madrid
Clinica Universidad De Navarra
Servicio de Oncologia Medica, Calle Marquesado De Santa Marta 1, 28027, Madrid
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2026-01-15 | Belgium | Acceptable with conditions 2026-04-27
|
2026-04-28 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2026-05-08 | Acceptable with conditions 2026-04-27
|
2026-05-08 |