Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ended
Participants planned
200
Countries
1
Sites
10
Hematologic tumors
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]
- Trial duration
- 10 May 2024 → 27 Oct 2025
- Decision date (initial)
- 2024-03-25
- 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
Hematologic tumors
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | LLT | 10066481 | Hematological malignancy | 10029104 |
| 21.1 | LLT | 10065252 | Solid tumor | 10029104 |
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
- Matt Patricelli
Public contact point
- Organisation
- Vividion Therapeutics Inc.
- Contact name
- Jenna Golberg
Locations
1 EU/EEA country · 10 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Spain | Ended | 40 | 10 |
| Rest of world
Australia, United States
|
— | 160 | — |
Investigational sites
Hospital Universitari Dexeus Grupo Quironsalud
Oncology, Calle De Sabino Arana 5-19, 08028, Barcelona
Hospital Hm Nou Delfos
Medical Oncology, Avinguda De Vallcarca 151, 08023, Barcelona
Hospital Universitario Hm Sanchinarro
Medical Oncology, Calle Ona 10, 28050, Madrid
Hospital General Universitario Gregorio Maranon
Medical Oncology, Calle Del Doctor Esquerdo 46, 28009, Madrid
Hospital Universitario Ramon Y Cajal
Oncology, Carretera Del Colmenar Viejo Km 9 100, Por El Pardo, Madrid
Hospital Universitario Fundacion Jimenez Diaz
Medical Oncology, Avenida De Los Reyes Catolicos 2, 28040, Madrid
Hospital Universitario Quironsalud Madrid
Medical Oncology, Calle De Diego De Velazquez 1, 28223, Pozuelo De Alarcon
Hospital Universitario 12 De Octubre
Medical Oncology, Bloque D, Avenida De Cordoba Sn, Madrid
Hospital Universitari Vall D Hebron
Medical Oncology, Edificio Materno-Infantil, Passeig De La Vall D'hebron 119-129, Barcelona
Clinica Universidad De Navarra
Medical Immunology and Immunotherapy, Pio XII Etorbidea 36, 31008, Pamplona
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 |
|---|---|---|---|---|---|
| Spain | 2024-05-10 | 2024-06-04 | 2025-09-12 |
Application history
7 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-12-15 | Spain | Acceptable 2024-03-25
|
2024-03-25 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-04-18 | Spain | Acceptable | 2024-07-01 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2024-07-17 | Spain | Acceptable 2024-09-09
|
2024-09-10 |
| 4 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2024-10-15 | Spain | 2024-10-15 | |
| 5 | SUBSTANTIAL MODIFICATION | SM-3 | 2024-11-20 | Spain | Acceptable 2025-02-18
|
2025-03-05 |
| 6 | SUBSTANTIAL MODIFICATION | SM-4 | 2025-03-18 | Spain | Acceptable 2025-04-29
|
2025-05-08 |
| 7 | SUBSTANTIAL MODIFICATION | SM-5 | 2025-08-08 | Spain | Acceptable 2025-09-22
|
2025-10-20 |