Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ongoing, recruiting
Participants planned
100
Countries
4
Sites
13
Solid tumors
Key facts
- Sponsor
- CDR-Life AG
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 29 May 2024 → ongoing
- Decision date (initial)
- 2024-06-28
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2023-508808-38-00
- WHO UTN
- U1111-1299-0120
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Solid tumors
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | LLT | 10065252 | Solid tumor | 10029104 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
CDR-Life AG
- Sponsor organisation
- CDR-Life AG
- Address
- Todistrasse 46
- City
- Horgen
- Postcode
- 8810
- Country
- Switzerland
Scientific contact point
- Organisation
- CDR-Life AG
- Contact name
- Clare Price
Public contact point
- Organisation
- CDR-Life AG
- Contact name
- Clare Price
Locations
4 EU/EEA countries · 13 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Belgium | Ongoing, recruiting | 15 | 4 |
| Denmark | Ongoing, recruiting | 10 | 1 |
| Italy | Ongoing, recruiting | 13 | 2 |
| Spain | Ongoing, recruiting | 20 | 6 |
| Rest of world
United States
|
— | 42 | — |
Investigational sites
Cliniques Universitaires Saint-Luc
Oncology, Hippokrateslaan 10, Batiment 54, Sint-Lambrechts-Woluwe
Universitair Ziekenhuis Gent
Oncology, Corneel Heymanslaan 10, 9000, Gent
Institut Jules Bordet
Oncology, Mijlenmeersstraat 90, 1070, Anderlecht
Antwerp University Hospital
Oncology, Drie Eikenstraat 655, 2650, Edegem
Rigshospitalet
Oncology, Blegdamsvej 9, 2100, Copenhagen Oe
Istituto Europeo Di Oncologia S.r.l.
Oncology, Via Giuseppe Ripamonti 435, 20141, Milan
Humanitas Mirasole S.p.A.
Oncology, Via Alessandro Manzoni 56, 20089, Rozzano
Vall D'hebron Institut De Recerca
Oncology, Passeig De La Vall D'hebron 119-129, 08035, Barcelona
Hospital Universitario 12 De Octubre
Oncology, Bloque D, Avenida De Cordoba Sn, Madrid
Institut Catala D'oncologia
Oncology, Avinguda De La Gran Via De L'hospitalet 199-203, 08908, L'hospitalet De Llobregat
Hospital Universitario Hm Sanchinarro
Oncology, Calle Ona 10, 28050, Madrid
Instituto De Investigacion Sanitaria Fundacion Para La Investigacion Del Hospital Clinico De Valencia-INCLIVA
Oncology, Avenida Menendez Y Pelayo 4, 46010, Valencia
Hospital Universitario Y Politecnico La Fe
Oncology, Avenida De Fernando Abril Martorell 106, 46026, Valencia
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 | 2024-10-02 | 2024-10-08 | |||
| Denmark | 2024-05-29 | 2024-08-02 | |||
| Italy | 2025-01-28 | 2025-01-29 | |||
| Spain | 2024-12-17 | 2024-12-26 |
Application history
10 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-01-24 | Denmark | Acceptable 2024-04-26
|
2024-04-28 |
| 2 | SUBSEQUENT ADDITION OF MSC | APP-2 | 2024-05-10 | 2024-06-28 | ||
| 3 | SUBSEQUENT ADDITION OF MSC | APP-3 | 2024-05-10 | Acceptable 2024-04-26
|
2024-07-31 | |
| 4 | SUBSEQUENT ADDITION OF MSC | APP-4 | 2024-05-10 | Acceptable 2024-04-26
|
2024-06-18 | |
| 5 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-09-06 | Denmark | Acceptable 2024-11-29
|
2024-11-29 |
| 6 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-01-27 | Acceptable 2024-11-29
|
2025-01-27 | |
| 7 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-04-10 | Denmark | Acceptable 2025-05-28
|
2025-05-30 |
| 8 | SUBSTANTIAL MODIFICATION | SM-4 | 2025-09-18 | Acceptable | 2025-09-26 | |
| 9 | SUBSTANTIAL MODIFICATION | SM-5 | 2025-09-26 | Denmark | Acceptable 2025-11-06
|
2025-11-06 |
| 10 | SUBSTANTIAL MODIFICATION | SM-6 | 2026-01-27 | Denmark | Acceptable 2026-04-23
|
2026-04-24 |