Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Authorised, recruiting
Participants planned
246
Countries
4
Sites
17
Advanced Solid Tumors
Key facts
- Sponsor
- Synnovation Therapeutics Inc.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 24 Jul 2025 → ongoing
- Decision date (initial)
- 2025-12-23
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2025-520557-36-00
- ClinicalTrials.gov
- NCT06220864
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Advanced Solid Tumors
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Synnovation Therapeutics Inc.
- Sponsor organisation
- Synnovation Therapeutics Inc.
- Address
- 200 Powder Mill Road E500
- City
- Wilmington
- Postcode
- 19803-2907
- Country
- United States
Scientific contact point
- Organisation
- Synnovation Therapeutics Inc.
- Contact name
- Dr Kevin O'Hayer
Public contact point
- Organisation
- Synnovation Therapeutics Inc.
- Contact name
- Dr Kevin O'Hayer
Locations
4 EU/EEA countries · 17 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Belgium | Authorised, recruitment pending | 20 | 4 |
| France | Ongoing, recruiting | 20 | 5 |
| Italy | Ongoing, recruiting | 20 | 3 |
| Spain | Ongoing, recruiting | 19 | 5 |
| Rest of world
Australia, United Kingdom, United States, Canada
|
— | 167 | — |
Investigational sites
Algemeen Ziekenhuis Groeninge
Urology, President Kennedylaan 4, 8500, Kortrijk
Institut Jules Bordet
Oncology, Mijlenmeersstraat 90, 1070, Anderlecht
Universitair Ziekenhuis Antwerpen
Oncology, Drie Eikenstraat 655, 2650, Edegem
Az Maria Middelares Gent
Medical Oncology & hematology, Buitenring-Sint-Denijs 30, 9000, Gent
Institut Gustave Roussy
DITEP, 114 Rue Edouard Vaillant, 94800, Villejuif
Institut De Cancerologie De L Ouest
Medical, Boulevard Jacques Monod, 44805, Saint-Herblain Cedex
Institut Bergonie
Medical Oncology, 180 R De Saint Genes, 229 Cours De L Argonne, Bordeaux
Centre Leon Berard
Medical Oncology, 28 Rue Laennec, 69008, Lyon
Institut Paoli Calmettes
Oncology, 232 Boulevard De Sainte Marguerite, Bp 156, Marseille
Ospedale San Raffaele S.r.l.
Oncology, Via Olgettina 60, 20132, Milan
Humanitas Mirasole S.p.A.
Oncology, Via Alessandro Manzoni 56, 20089, Rozzano
Istituto Europeo Di Oncologia S.r.l.
Oncology, Via Giuseppe Ripamonti 435, 20141, Milan
Hospital Universitario Quironsalud Madrid
NEXT Madrid Phase I trials, Calle De Diego De Velazquez 1, 28223, Pozuelo De Alarcon
Hospital Quironsalud Barcelona
Phase Unit I, Placa D'alfonso Comin 5-7, 08023, Barcelona
Hospital Universitari Vall D Hebron
Medical Oncology, Passeig De La Vall D'Hebron 119-129, 08035, Barcelona
Hospital Clinic De Barcelona
Medical Oncology, Calle Villarroel 170, 08036, Barcelona
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 |
|---|---|---|---|---|---|
| France | 2025-08-08 | 2025-09-16 | |||
| Italy | 2025-09-19 | 2025-09-19 | |||
| Spain | 2025-07-24 | 2025-10-27 |
Application history
5 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-03-15 | Italy | Acceptable 2025-07-07
|
2025-07-08 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-07-22 | Acceptable | 2025-07-24 | |
| 3 | SUBSEQUENT ADDITION OF MSC | APP-3 | 2025-10-15 | Acceptable 2025-07-07
|
2025-12-23 | |
| 4 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-12-31 | Acceptable | 2026-01-20 | |
| 5 | SUBSTANTIAL MODIFICATION | SM-3 | 2026-02-27 | Italy | Acceptable 2026-05-28
|
2026-05-29 |