Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Authorised, recruitment pending
Participants planned
40
Countries
1
Sites
3
Patients with advanced refractory solid tumors.
Key facts
- Sponsor
- Applied Research Using Omic Sciences S.L.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Decision date (initial)
- 2025-04-11
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2024-517569-18-00
- ClinicalTrials.gov
- NCT06652529
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Patients with advanced refractory solid tumors.
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Applied Research Using Omic Sciences S.L.
- Sponsor organisation
- Applied Research Using Omic Sciences S.L.
- Address
- Ex Victor Pradera, Calle De Can Roses 45 Calle De Can Roses 45
- City
- Cornella De Llobregat
- Postcode
- 08940
- Country
- Spain
Scientific contact point
- Organisation
- Applied Research Using Omic Sciences S.L.
- Contact name
- Carme Plasencia
Public contact point
- Organisation
- Applied Research Using Omic Sciences S.L.
- Contact name
- Carme Plasencia
Locations
1 EU/EEA country · 3 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Spain | Authorised, recruitment pending | 40 | 3 |
| Rest of world | — | 0 | — |
Investigational sites
Institut Catala D'oncologia
Oncology, Avinguda De La Gran Via De L'hospitalet 199-203, 08908, L'hospitalet De Llobregat
Hospital Universitario Fundacion Jimenez Diaz
Oncology, Avenida De Los Reyes Catolicos 2, 28040, Madrid
Institut Catala D'oncologia
Oncology, Carretera Canyet S/n, 08916, Badalona
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-01-15 | Spain | Acceptable 2025-04-11
|
2025-04-11 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-05-06 | Spain | Acceptable 2025-04-11
|
2025-05-06 |