Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ongoing, recruitment ended
Participants planned
100
Countries
9
Sites
28
Thoracic tumors with homozygous MTAP-deletion
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
- 28 Feb 2025 → ongoing
- Decision date (initial)
- 2024-08-05
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2024-511253-21-00
- WHO UTN
- U1111-1303-8190
- ClinicalTrials.gov
- NCT06333951
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Thoracic tumors with homozygous MTAP-deletion
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | 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
9 EU/EEA countries · 28 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Austria | Ongoing, recruitment ended | 2 | 2 |
| Belgium | Ended | 6 | 1 |
| France | Ongoing, recruitment ended | 5 | 4 |
| Germany | Ongoing, recruitment ended | 3 | 3 |
| Greece | Ongoing, recruitment ended | 6 | 5 |
| Italy | Ended | 4 | 4 |
| Netherlands | Ended | 3 | 1 |
| Poland | Ongoing, recruitment ended | 7 | 5 |
| Spain | Ended | 6 | 3 |
| Rest of world
Argentina, Brazil, Hong Kong, Korea, Republic of, Taiwan, Canada, United States, Australia, Japan, China, Turkey
|
— | 58 | — |
Investigational sites
Medical University Of Graz
Department of Internal Medicine, Neue Stiftingtalstrasse 6, 8010, Graz
Medizinische Universitaet Innsbruck
Department of Internal Medicine V, Anichstrasse 35, 6020, Innsbruck
Centre Hospitalier Regional De Marseille
Centre d'Essais Précoces de Cancérologie de Marseille, 264 Rue Saint Pierre, 13005, Marseille
Institut De Cancerologie De L Ouest
Service Oncologie, Bd Du Professeur Jacques Monod, 44800, St Herblain
Institut Gustave Roussy
Service d'Oncologie Multidisciplinaire et Innovation Thérapeutiques, 114 Rue Edouard Vaillant, 94800, Villejuif
Institut Bergonie
Service d'Oncologie Médicale, 180 R De Saint Genes, 229 Cours De L Argonne, Bordeaux
Universitaetsklinikum Essen AöR
Department of Medical Oncology, Hufelandstrasse 55, Holsterhausen, Essen
Universitaetsklinikum Wuerzburg AöR
Comprehensive Cancer Center Mainfranken (CCCM), Straubmuehlweg 2a, Grombuehl, Wuerzburg
Thoraxklinik Heidelberg gGmbH
Thoraxklinik Heidelberg gGmbH, Roentgenstrasse 1, Rohrbach, Heidelberg
St. Luke's Hospital S.A.
Oncology Department, Harilaou Trikoupi Str. 3, 552 36, Thessaloniki
Athens Medical Center S.A.
4th Department of Medical Oncology, Pylea, Asklipiou 10, Thessaloniki
General Hospital Of Thessaloniki Papageorgiou
Molecular Medicine Clinic/Clinical Trial Unit, Ring Road Of Thessaloniki, Ministry Of Pavlos Melas, Efkarpia
Alexandra Hospital
Oncology Department / Department of Clinical Therapeutics, Vassilissas Sofias Avenue 80, 115 28, Athens
Henry Dunant Hospital Center
4™ Oncology dept. & Clinical Trials Unit, 107 Mesogeion Avenue, 115 26, Athens
ASST Grande Ospedale Metropolitano Niguarda
Dipartimento di Ematologia ed Oncologia, Piazza Dell'ospedale Maggiore 3, 20162, Milan
Centro Ricerche Cliniche Di Verona S.r.l.
Centro di Ricerche Cliniche, Piazzale Ludovico Antonio Scuro 10, 37134, Verona
Fondazione IRCCS Istituto Nazionale Dei Tumori
Oncologia Medica 1, Via Giacomo Venezian 1, 20133, Milan
Humanitas Mirasole S.p.A.
Oncologia Medica ed Ematologia, Via Alessandro Manzoni 56, 20089, Rozzano
Stichting Radboud universitair medisch centrum
Medical Oncology, Geert Grooteplein Zuid 10, 6525 GA, Nijmegen
Futuremeds Sp. z o.o.
Oncology, Ul. Mikolaja Kopernika 32, 31-501, Cracow
Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy
Oncology, Ul. Wybrzeze Armii Krajowej 15, 44-102, Gliwice
Uniwersyteckie Centrum Kliniczne
Oncology, Ul. Mariana Smoluchowskiego 17, 80-214, Gdansk
Centrum Medyczne Hope Clinic Sebastian Szklener
Oncology, Ul. Naleczowska 18A/U7, 20-701, Lublin
Instytut Centrum Zdrowia Matki Polki
Oncology, Ul. Rzgowska 281/289, 93-338, Lodz
Hospital Clinic De Barcelona
Servicio de Oncologia Medica, Calle Villarroel 170, 08036, Barcelona
Hospital Universitari Vall D Hebron
Servicio de Oncologia, Edificio Materno-Infantil, Passeig De La Vall D'hebron 119-129, Barcelona
Hospital Universitario 12 De Octubre
Servicio de Oncologia, Bloque D, Avenida De Cordoba Sn, 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 |
|---|---|---|---|---|---|
| Austria | 2025-03-13 | 2025-04-30 | 2026-04-30 | ||
| Belgium | 2025-03-26 | 2025-10-03 | 2026-04-30 | ||
| France | 2025-03-05 | 2025-04-02 | 2026-04-30 | ||
| Germany | 2025-03-14 | 2025-04-11 | 2026-04-30 | ||
| Greece | 2025-02-28 | 2025-03-10 | 2026-04-30 | ||
| Italy | 2025-02-28 | 2025-04-30 | 2026-04-30 | ||
| Netherlands | 2025-04-14 | 2025-07-07 | 2026-04-30 | ||
| Poland | 2025-03-17 | 2025-04-04 | 2026-04-30 | ||
| Spain | 2025-03-06 | 2025-04-10 | 2026-04-30 |
Application history
8 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-04-16 | Belgium | Acceptable with conditions 2024-07-29
|
2024-07-29 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-10-28 | Belgium | Acceptable 2025-01-14
|
2025-01-14 |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-02-19 | Belgium | Acceptable 2025-01-14
|
2025-02-19 |
| 4 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-04-01 | Belgium | Acceptable 2025-06-26
|
2025-06-26 |
| 5 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2025-08-12 | Acceptable 2025-06-26
|
2025-08-12 | |
| 6 | SUBSTANTIAL MODIFICATION | SM-3 | 2025-11-06 | Belgium | Acceptable 2026-02-17
|
2026-02-17 |
| 7 | NON SUBSTANTIAL MODIFICATION | NSM-3 | 2026-03-03 | Acceptable 2026-02-17
|
2026-03-03 | |
| 8 | NON SUBSTANTIAL MODIFICATION | NSM-4 | 2026-04-01 | Acceptable 2026-02-17
|
2026-04-01 |