Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ongoing, recruiting
Participants planned
42
Countries
1
Sites
7
Solid Malignancies
Key facts
- Sponsor
- Mestag Therapeutics Limited
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 1 Apr 2026 → ongoing
- Decision date (initial)
- 2026-03-13
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Solid Malignancies
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | LLT | 10065252 | Solid tumor | 10029104 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Mestag Therapeutics Limited
- Sponsor organisation
- Mestag Therapeutics Limited
- Address
- Suite 15, Science Village, Chesterford Park, Little Chesterford Science Village Chesterford Park
- City
- Saffron Walden
- Postcode
- CB10 1XL
- Country
- United Kingdom
Scientific contact point
- Organisation
- Mestag Therapeutics Limited
- Contact name
- Colin Lunt
Public contact point
- Organisation
- Mestag Therapeutics Limited
- Contact name
- Colin Lunt
Locations
1 EU/EEA country · 7 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Spain | Ongoing, recruiting | 42 | 7 |
| Rest of world | — | 0 | — |
Investigational sites
Hospital Quironsalud Barcelona
Instituto de Oncología de Barcelona, Placa D'alfonso Comin 5-7, 08023, Barcelona
Hospital Universitario 12 De Octubre
Oncología Médica, Avenida De Cordoba Sn, 28041, Madrid
Hospital Universitario Fundacion Jimenez Diaz
Oncología, Avenida De Los Reyes Catolicos 2, 28040, Madrid
Hospital Universitario Hm Sanchinarro
Centro Integral Oncológico Clara Campall (CIOCC) Phase I trials unit, Calle Ona 10, 28050, Madrid
Clinica Universidad De Navarra
Inmunología médica & inmunoterapía, Pio XII Etorbidea 36, 31008, Pamplona
Hospital Universitari Vall D Hebron
Oncología Médica, Passeig De La Vall D'Hebron 119-129, 08035, Barcelona
Hospital Clinico Universitario De Valencia
Oncología Médica, 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 | 2026-04-01 | 2026-04-09 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2026-02-02 | Spain | Acceptable 2026-03-11
|
2026-03-13 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2026-07-03 | Spain | Acceptable 2026-03-11
|
2026-07-03 |