Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Authorised, recruiting
Participants planned
92
Countries
5
Sites
12
Participants with Advanced Solid Tumors
Key facts
- Sponsor
- Epics Therapeutics
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Not possible to specify
- Trial duration
- 22 Jul 2025 → ongoing
- Decision date (initial)
- 2025-07-15
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Participants with Advanced Solid Tumors
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Epics Therapeutics
- Sponsor organisation
- Epics Therapeutics
- Address
- Rue Adrienne Bolland 47
- City
- Charleroi
- Postcode
- 6041
- Country
- Belgium
Scientific contact point
- Organisation
- Epics Therapeutics
- Contact name
- Medical Director
Public contact point
- Organisation
- Epics Therapeutics
- Contact name
- CEO & CSO
Locations
5 EU/EEA countries · 12 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Belgium | Ongoing, recruiting | 32 | 4 |
| Czechia | Ongoing, recruiting | 17 | 2 |
| France | Ended | 8 | 1 |
| Netherlands | Ongoing, recruiting | 9 | 2 |
| Spain | Ongoing, recruiting | 26 | 3 |
| Rest of world | — | 0 | — |
Investigational sites
Universitair Ziekenhuis Gent
Medical oncology, Corneel Heymanslaan 10, 9000, Gent
UZ Leuven
Department of general medical oncology, Herestraat 49, 3000, Leuven
Cliniques Universitaires Saint-Luc
Medical Oncology / Institut Roi Albert II, Avenue Hippocrate 10, 1200, Bruxelles
Institut Jules Bordet
Oncology, Mijlenmeersstraat 90, 1070, Anderlecht
Masarykuv Onkologicky Ustav
Clinic of Comprehensive Cancer Care, Zluty Kopec 543/7, Stare Brno, Brno-Stred
University Hospital Olomouc
Department of Oncology, Zdravotniku 248/7, 779 00, Olomouc
Institut Gustave Roussy
Département d'innovation Thérapeutique et des Essais Précoces (DITEP), 114 Rue Edouard Vaillant, 94800, Villejuif
Netherlands Cancer Institute
Department of medical oncology, Plesmanlaan 121, 1066 CX, Amsterdam
Universitair Medisch Centrum Groningen
Department of Medical Oncology, Hanzeplein 1, 9713 GZ, Groningen
Hospital Universitari Vall D Hebron
Vall d’Hebron Institute of Oncology, Passeig De La Vall D'Hebron 119-129, 08035, Barcelona
Fundacion Publica Galega Instituto De Investigacion Sanitaria De Santiago De Compostela
Oncology Department, Hospital Clínico Universitario Santiago de Compostela, Travesia Da Choupana S/N, 15706, Santiago De Compostela
Hospital Universitario Hm Sanchinarro
Centro Integral Oncológico Clara Campall (CIOCC) Phase I trials unit, Calle Ona 10, 28050, 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 |
|---|---|---|---|---|---|
| Belgium | 2025-09-02 | 2025-10-08 | |||
| Czechia | 2025-08-07 | 2025-08-13 | |||
| Netherlands | 2026-04-24 | 2026-05-04 | |||
| Spain | 2025-07-22 | 2025-08-06 |
Application history
10 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-03-27 | Belgium | Acceptable with conditions 2025-07-14
|
2025-07-15 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-07-30 | Belgium | Acceptable with conditions 2025-07-14
|
2025-07-30 |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2025-07-31 | Acceptable with conditions 2025-07-14
|
2025-07-31 | |
| 4 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-08-05 | Belgium | Acceptable with conditions | 2025-09-04 |
| 5 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-08-06 | Acceptable with conditions | 2025-08-13 | |
| 6 | SUBSTANTIAL MODIFICATION | SM-3 | 2025-08-07 | Acceptable with conditions | 2025-08-26 | |
| 7 | SUBSTANTIAL MODIFICATION | SM-4 | 2025-08-07 | Acceptable with conditions | 2025-10-22 | |
| 8 | SUBSEQUENT ADDITION OF MSC | APP-8 | 2025-08-12 | Acceptable with conditions 2025-07-14
|
2025-10-29 | |
| 9 | NON SUBSTANTIAL MODIFICATION | NSM-3 | 2025-10-30 | Acceptable with conditions 2025-07-14
|
2025-10-30 | |
| 10 | SUBSTANTIAL MODIFICATION | SM-5 | 2025-12-17 | Belgium | Acceptable 2026-04-08
|
2026-04-09 |