Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ended
Participants planned
417
Countries
6
Sites
25
Melanoma
Key facts
- Sponsor
- H e x a l AG
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 15 May 2024 → 6 May 2026
- Decision date (initial)
- 2024-04-15
- 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
Melanoma
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | PT | 10025669 | Malignant melanoma stage II | 100000004864 |
| 21.1 | PT | 10025670 | Malignant melanoma stage III | 100000004864 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
H e x a l AG
- Sponsor organisation
- H e x a l AG
- Address
- Industriestrasse 25
- City
- Holzkirchen
- Postcode
- 83607
- Country
- Germany
Scientific contact point
- Organisation
- H e x a l AG
- Contact name
- Biosimilar Clinical Trials Information Point
Public contact point
- Organisation
- H e x a l AG
- Contact name
- Biosimilar Clinical Trials Information Point
Locations
6 EU/EEA countries · 25 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Ended | 8 | 2 |
| Germany | Ended | 14 | 3 |
| Italy | Ended | 20 | 4 |
| Lithuania | Ended | 10 | 2 |
| Romania | Ended | 25 | 2 |
| Spain | Ended | 59 | 12 |
| Rest of world
Korea, Republic of, Mexico, South Africa, Philippines, Malaysia, Georgia, Brazil, United States, Turkey, Serbia, Bosnia and Herzegovina
|
— | 281 | — |
Investigational sites
Besancon University Hospital Center
Oncologie médicale, 3 Boulevard Alexander Fleming, Cs 81816, Besancon Cedex
Centre Hospitalier Universitaire De Nantes
Dermatologie, 1 Place Alexis Ricordeau, 44000, Nantes
Fachklinik Hornheide e.V.
Oncology, Dorbaumstrasse 300, Handorf, Muenster
Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöR
Dermatology, Langenbeckstrasse 1, Oberstadt, Mainz
Eberhard Karls Universitaet Tuebingen
Dermatology, Liebermeisterstrasse 25, Innenstadt, Tuebingen
IRCCS Istituto Nazionale Tumori Fondazione Pascale
SC Oncologia Clinica Sperimentale del Melanoma, Immunoterapia e Terapie Innovative, Via Mariano Semmola 52, 80131, Naples
Azienda Ospedaliera Universitaria Mater Domini
Centro di Sperimentazioni di Fase I in Oncologia Medica e Oncoematologia-UOC Oncologia Medica Trasla, Viale Tommaso Campanella 115, 88100, Catanzaro
Humanitas Research Hospital
Unità di Fase I - Istituto Clinico Humanitas, Via Alessandro Manzoni 56, 20089, Rozzano
Fondazione IRCCS Policlinico San Matteo
San Matteo Phase I Clinical Trial Unit and Experimental Therapy, Viale Camillo Golgi 19, 27100, Pavia
Klaipedos universiteto ligonine VšĮ
2600: Chemotherapy, Liepojos G. 41, Klaipedos M. Sav., Klaipeda
Nacionalinis vezio institutas
Conservative Tumour Therapy, Santariskiu G. 1, Vilniaus M. Sav., Vilnius
Institutul Oncologic Prof. Dr. Alexandru Trestioreanu Bucuresti
Medical Oncology II Department, Radiotherapy I Department, Soseaua Fundeni 252, 022328, Bucharest
Institute Of Oncology Prof. Dr. Ion Chiricuta Cluj-Napoca
Radiotherapy Department, Strada Republicii 34-36, 400015, Cluj-Napoca
Hospital Universitario Y Politecnico La Fe
Onco-Hematologia Pediatrica, Avenida De Fernando Abril Martorell 106, 46026, Valencia
University Clinical Hospital Virgen De La Arrixaca
Oncología, Carretera De Cartagena Sn, El Palmar, Murcia
Hospital Universitario Fundacion Jimenez Diaz
Oncología Médica, Avenida De Los Reyes Catolicos 2, 28040, Madrid
Hospital Universitario Virgen De La Macarena
Oncología Médica, Avenida Del Doctor Fedriani 3, 41009, Sevilla
Institut Catala D'oncologia
Oncología Médica, Carretera Canyet S/n, 08916, Badalona
Fundacion Instituto Valenciano De Oncologia
Oncología, Calle Professor Beltran Baguena 8, 46009, Valencia
Hospital De La Santa Creu I Sant Pau
Oncología Médica, Carrer De San Quinti 89, 08041, Barcelona
University Hospital Virgen Del Rocio S.L.
Oncología, Avenida De Manuel Siurot S/n, 41013, Sevilla
Hospital San Pedro De Alcantara
Oncología, Avenida De Pablo Naranjo Porras S/n, 10002, Caceres
Hospital Unviersitario Miguel Servet
Oncología, Paseo De Isabel La Catolica 1-3, 50009, Zaragoza
Complexo Hospitalario Universitario De Santiago
Oncología Médica, Calle Choupana Da S/n, 15706, Santiago De Compostela
Hospital Universitari Vall D Hebron
Oncología Médica, 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 | 2025-07-10 | 2026-04-24 | 2025-07-10 | 2025-11-18 | |
| Germany | 2024-08-01 | 2026-04-21 | 2024-08-01 | 2025-11-18 | |
| Italy | 2024-11-19 | 2025-11-20 | 2024-11-19 | 2025-11-18 | |
| Lithuania | 2024-09-23 | 2026-04-16 | 2024-09-23 | 2025-11-18 | |
| Romania | 2024-05-15 | 2026-05-05 | 2024-05-15 | 2025-11-18 | |
| Spain | 2024-05-29 | 2026-04-21 | 2024-05-29 | 2025-11-18 |
Application history
12 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-11-30 | Germany | Acceptable 2024-04-09
|
2024-04-09 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-04-17 | Acceptable | 2024-05-15 | |
| 3 | SUBSTANTIAL MODIFICATION | SM-5 | 2024-04-18 | Germany | Acceptable | 2024-05-02 |
| 4 | SUBSTANTIAL MODIFICATION | SM-2 | 2024-04-22 | Acceptable | 2024-07-02 | |
| 5 | SUBSTANTIAL MODIFICATION | SM-3 | 2024-04-22 | Acceptable | 2024-05-20 | |
| 6 | SUBSTANTIAL MODIFICATION | SM-4 | 2024-04-22 | Acceptable | 2024-06-03 | |
| 7 | SUBSTANTIAL MODIFICATION | SM-7 | 2024-06-04 | Acceptable | 2024-06-14 | |
| 8 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2024-10-14 | Germany | Acceptable | 2024-10-14 |
| 9 | SUBSTANTIAL MODIFICATION | SM-8 | 2024-11-21 | Germany | Acceptable 2025-02-10
|
2025-02-11 |
| 10 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2025-07-10 | Acceptable 2025-02-10
|
2025-07-10 | |
| 11 | NON SUBSTANTIAL MODIFICATION | NSM-3 | 2025-08-04 | Germany | Acceptable 2025-02-10
|
2025-08-04 |
| 12 | SUBSTANTIAL MODIFICATION | SM-9 | 2025-10-13 | Germany | Acceptable | 2025-11-10 |