Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ongoing, recruiting
Participants planned
285
Countries
1
Sites
11
Dose escalation: Advanced Solid Tumors Dose Expansion: Squamous non-small cell lung cancer
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
- 5 Aug 2024 → ongoing
- Decision date (initial)
- 2023-11-16
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2023-506199-28-00
- ClinicalTrials.gov
- NCT05954312
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Dose escalation: Advanced Solid Tumors Dose Expansion: Squamous non-small cell lung cancer
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | LLT | 10065252 | Solid tumor | 10029104 |
| 24.0 | LLT | 10085300 | Squamous non-small cell lung cancer | 100000004848 |
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 Goldberg
Locations
1 EU/EEA country · 11 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Spain | Ongoing, recruiting | 65 | 11 |
| Rest of world
Korea, Republic of, United States
|
— | 220 | — |
Investigational sites
Hospital Hm Nou Delfos
Oncology, Avinguda De Vallcarca 151, 08023, Barcelona
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 Oncology, Pio XII Etorbidea 36, 31008, Pamplona
Hospital Universitari Dexeus Grupo Quironsalud
Medical Oncology, Calle De Sabino Arana 5-19, 08028, Barcelona
Hospital Universitario Ramon Y Cajal
Medical Oncology, Carretera Del Colmenar Viejo Km 9 100, Por El Pardo, Madrid
Hospital General Universitario Gregorio Maranon
Medical Oncology, Calle Del Doctor Esquerdo 46, 28009, Madrid
Hospital Universitario Hm Sanchinarro
Oncology, Calle Ona 10, 28050, Madrid
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 Clinico Universitario De Valencia
Medical Oncology, Avenida Blasco Ibanez 17, 46010, Valencia
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 | 2024-01-04 | 2024-01-12 |
Oversight and notifications
Regulatory notifications under CTR Articles 38, 52, 53, 54 and 77
Temporary halts 1 · Art. 38 CTR
Temporary halt TH-21948
- Halt date
- 2024-04-12
- Member states concerned
- Spain
- Publication date
- 2024-04-18
- Reason
- Safety related (clinical or pre-clinical results)
- Explanation
- Please kindly refer to the attached Safety Report for Health Authorities and Ethics Committees. In addition to the report please be informed that on 18-Apr-2024, a follow up report was received with PRES reported as an event with fatal outcome.
- Follow-up measures
- Please kindly refer to the attached Safety Report for Health Authorities and Ethics Committees.
- Benefit-risk balance changed
- Yes
- Treatment stopped
- No
Application history
8 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-08-15 | Spain | Acceptable 2023-11-16
|
2023-11-16 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2023-12-15 | Spain | Acceptable 2024-02-06
|
2024-02-06 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2024-04-01 | Spain | Acceptable 2024-05-23
|
2024-05-27 |
| 4 | SUBSTANTIAL MODIFICATION | SM-3 | 2024-06-19 | Spain | Acceptable 2024-08-02
|
2024-08-02 |
| 5 | SUBSTANTIAL MODIFICATION | SM-4 | 2024-10-02 | Spain | Acceptable 2024-11-18
|
2024-12-13 |
| 6 | SUBSTANTIAL MODIFICATION | SM-5 | 2025-02-21 | Spain | Acceptable 2025-04-25
|
2025-05-13 |
| 7 | SUBSTANTIAL MODIFICATION | SM-6 | 2025-06-06 | Spain | Acceptable 2025-07-23
|
2025-07-31 |
| 8 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-10-10 | Spain | Acceptable 2025-07-23
|
2025-10-10 |