Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Authorised, recruitment pending
Participants planned
152
Countries
1
Sites
4
Advanced Solid Tumours
Key facts
- Sponsor
- Vividion Therapeutics Inc.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Decision date (initial)
- 2025-09-26
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2025-522148-42-00
- ClinicalTrials.gov
- NCT06804824
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Advanced Solid Tumours
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Vividion Therapeutics Inc.
- Sponsor organisation
- Vividion Therapeutics Inc.
- Address
- 5820 Nancy Ridge Drive
- City
- San Diego
- Postcode
- 92121-2842
- Country
- United States
Scientific contact point
- Organisation
- Vividion Therapeutics Inc.
- Contact name
- Rajesh Belani
Public contact point
- Organisation
- Vividion Therapeutics Inc.
- Contact name
- Rajesh Belani
Locations
1 EU/EEA country · 4 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Spain | Authorised, recruitment pending | 32 | 4 |
| Rest of world
Korea, Republic of, United States, Australia
|
— | 120 | — |
Investigational sites
Hospital Universitario Fundacion Jimenez Diaz
Oncology, Avenida De Los Reyes Catolicos 2, 28040, Madrid
Hospital Universitario Quironsalud Madrid
Oncology, Calle De Diego De Velazquez 1, 28223, Pozuelo De Alarcon
Hospital Universitario Hm Sanchinarro
Oncology, Calle Ona 10, 28050, Madrid
Hospital Hm Nou Delfos
Oncology, Avinguda De Vallcarca 151, 08023, Barcelona
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-06-30 | Spain | Acceptable 2025-09-22
|
2025-09-26 |