Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ongoing, recruiting
Participants planned
295
Countries
4
Sites
9
Advanced solid 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
- 26 Feb 2024 → ongoing
- Decision date (initial)
- 2024-02-26
- 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
Advanced solid tumors
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.0 | LLT | 10049280 | Solid tumour | 10029104 |
| 21.0 | LLT | 10080676 | Microsatellite instability | 10010331 |
| 22.0 | PT | 10078672 | DNA mismatch repair protein gene mutation | 100000004850 |
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, MD
Public contact point
- Organisation
- Vividion Therapeutics Inc.
- Contact name
- Rajesh Belani, MD
Locations
4 EU/EEA countries · 9 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Belgium | Ongoing, recruiting | 20 | 1 |
| Denmark | Ongoing, recruiting | 20 | 1 |
| France | Ongoing, recruiting | 20 | 2 |
| Spain | Ongoing, recruiting | 20 | 5 |
| Rest of world
New Zealand, Korea, Democratic People's Republic of, United Kingdom, Canada, Australia, United States, Malaysia
|
— | 215 | — |
Investigational sites
Rigshospitalet
Rigshospitalet; Fase 1 Enhed - Onkologi, Blegdamsvej 9, 2100, Copenhagen Oe
Centre Leon Berard
Medical Oncology, 28 Rue Laennec, 69008, Lyon
Institut Gustave Roussy
Medical Oncology - DITEP, 114 Rue Edouard Vaillant, 94800, Villejuif
Clinica Universidad De Navarra
Servicio de Oncología, Calle Marquesado De Santa Marta 1, 28027, Madrid
Hospital Clinico Universitario De Valencia
Servicio de Oncología, Avenida Blasco Ibanez 17, 46010, Valencia
Hospital Universitari Vall D Hebron
Servicio de Oncología, Edificio Materno-Infantil, Passeig De La Vall D'hebron 119-129, Barcelona
Hospital Universitario Hm Sanchinarro
Servicio de Oncología, Calle Ona 10, 28050, Madrid
Clinica Universidad De Navarra
Servicio de Oncología, Avenue Pio XII 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 |
|---|---|---|---|---|---|
| Belgium | 2024-03-07 | 2024-04-23 | |||
| Denmark | 2024-03-20 | 2024-05-13 | |||
| France | 2024-04-26 | 2024-05-03 | |||
| Spain | 2024-02-26 | 2024-03-11 |
Application history
8 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-12-06 | Denmark | Acceptable 2024-02-21
|
2024-02-22 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-07-12 | Denmark | Acceptable 2024-09-19
|
2024-09-19 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2024-11-05 | Denmark | Acceptable 2025-01-31
|
2025-01-31 |
| 4 | SUBSTANTIAL MODIFICATION | SM-3 | 2025-03-06 | Acceptable | 2025-03-19 | |
| 5 | SUBSTANTIAL MODIFICATION | SM-4 | 2025-04-04 | Denmark | Acceptable 2025-06-03
|
2025-06-04 |
| 6 | SUBSTANTIAL MODIFICATION | SM-6 | 2025-09-30 | Denmark | Acceptable 2025-10-06
|
2025-10-07 |
| 7 | SUBSTANTIAL MODIFICATION | SM-7 | 2025-10-28 | Denmark | Acceptable 2026-01-28
|
2026-02-02 |
| 8 | SUBSTANTIAL MODIFICATION | SM-8 | 2026-02-26 | Denmark | Acceptable 2026-05-21
|
2026-05-21 |