Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ended
Participants planned
260
Countries
3
Sites
9
Advanced solid tumors including non-small cell lung cancer (NSCLC), mesothelioma, pancreatic adenocarcinoma, head and neck carcinoma, ovarian cancer, cervical carcinoma, uterine carcinoma and breast cancer.
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
- 29 Sep 2023 → 22 Jan 2026
- Decision date (initial)
- 2023-08-23
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2022-502867-39-00
- WHO UTN
- U1111-1286-0652
- ClinicalTrials.gov
- NCT05800964
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Advanced solid tumors including non-small cell lung cancer (NSCLC), mesothelioma, pancreatic adenocarcinoma, head and neck carcinoma, ovarian cancer, cervical carcinoma, uterine carcinoma and breast cancer.
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | PT | 10017758 | Gastric cancer | 100000004864 |
| 20.0 | PT | 10027406 | Mesothelioma | 100000004864 |
| 20.0 | PT | 10046766 | Uterine cancer | 100000004864 |
| 21.1 | PT | 10067821 | Head and neck cancer | 100000004864 |
| 20.0 | PT | 10033128 | Ovarian cancer | 100000004864 |
| 20.0 | HLT | 10033632 | Pancreatic neoplasms | 10017947 |
| 21.1 | PT | 10061873 | Non-small cell lung cancer | 100000004864 |
| 20.0 | PT | 10006187 | Breast cancer | 100000004864 |
| 21.0 | PT | 10061451 | Colorectal cancer | 100000004864 |
| 21.1 | PT | 10008342 | Cervix carcinoma | 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
- 91320-1799
- 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 · 9 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Ended | 15 | 2 |
| Germany | Ended | 18 | 3 |
| Spain | Ended | 25 | 4 |
| Rest of world
Canada, Australia, Japan, Korea, Republic of, United Kingdom, United States
|
— | 202 | — |
Investigational sites
Institut Gustave Roussy
Departement de Medecine oncologique, 114 Rue Edouard Vaillant, 94800, Villejuif
Institut Claudius Regaud
Departement oncologie medicale, 1 Avenue Irene Joliot Curie, 31100, Toulouse
Technische Universitat Dresden
Innere Medizin und Hämatologie und Onkologie, Fetscherstrasse 74, Johannstadt-Nord, Dresden
Universitaetsklinikum Wuerzburg AöR
Interdisziplinäres Studienzentrum (ISZ) mit ECTU, Straubmuehlweg 2a, Grombuehl, Wuerzburg
Universitaetsklinikum Essen AöR
Westdeutsches Tumorzentrum Essen, Hufelandstrasse 55, Holsterhausen, Essen
Hospital Clinic De Barcelona
Servicio de Oncologia Medica, Calle Villarroel 170, 08036, Barcelona
Hospital Universitario Hm Sanchinarro
Start Madrid Sanchinarro, Calle Ona 10, 28050, Madrid
Hospital Universitario 12 De Octubre
Servicio de Oncologia, Bloque D, Avenida De Cordoba S/n, Madrid
Hospital Universitari Vall D Hebron
Servicio de Oncologia, Edificio Materno-Infantil, Passeig De La Vall D'hebron 119-129, 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 | 2023-10-11 | 2023-10-26 | 2025-11-06 | ||
| Germany | 2023-09-29 | 2023-10-23 | 2025-11-06 | ||
| Spain | 2023-10-23 | 2023-12-28 | 2025-11-06 |
Application history
6 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-04-27 | Spain | Acceptable 2023-08-21
|
2023-08-23 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2023-09-07 | Spain | Acceptable | 2023-09-13 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2023-10-02 | Spain | Acceptable 2023-11-14
|
2023-11-14 |
| 4 | SUBSTANTIAL MODIFICATION | SM-3 | 2024-01-19 | Spain | Acceptable 2024-03-27
|
2024-03-27 |
| 5 | SUBSTANTIAL MODIFICATION | SM-4 | 2024-05-24 | Spain | Acceptable 2024-07-30
|
2024-07-30 |
| 6 | SUBSTANTIAL MODIFICATION | SM-5 | 2025-04-02 | Spain | Acceptable 2025-06-23
|
2025-06-25 |