Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Authorised, recruitment pending
Participants planned
170
Countries
1
Sites
3
Advanced NSCLC
Key facts
- Sponsor
- TOLREMO therapeutics AG
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Decision date (initial)
- 2025-06-27
- 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 NSCLC
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 28.0 | PT | 10071975 | EGFR gene mutation | 100000004850 |
| 28.0 | LLT | 10069759 | KRAS mutation | 10018065 |
| 28.0 | PT | 10029521 | Non-small cell lung cancer stage IIIB | 100000004864 |
| 28.0 | PT | 10029522 | Non-small cell lung cancer stage IV | 100000004864 |
| 24.0 | LLT | 10085300 | Squamous non-small cell lung cancer | 100000004848 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
TOLREMO therapeutics AG
- Sponsor organisation
- TOLREMO therapeutics AG
- Address
- Hochbergerstrasse 60c
- City
- Basel
- Postcode
- 4057
- Country
- Switzerland
Scientific contact point
- Organisation
- TOLREMO therapeutics AG
- Contact name
- Chief Executive Officer
Public contact point
- Organisation
- TOLREMO therapeutics AG
- Contact name
- Chief Operating Officer
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
Switzerland, United States, United Kingdom
|
— | 130 | — |
Investigational sites
Hospital Quironsalud Barcelona
Phase I Unit, Placa D'alfonso Comin 5-7, 08023, Barcelona
Hospital Universitario 12 De Octubre
Therapeutic Innovation and Precision Medicine section, Avenida De Cordoba Sn, 28041, Madrid
Hospital Universitario Quironsalud Madrid
NEXT Madrid Phase I trials, Calle De Diego De Velazquez 1, 28223, Pozuelo De Alarcon
Application history
3 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-03-27 | Spain | Acceptable 2025-06-20
|
2025-06-27 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-11-20 | Spain | Acceptable 2026-02-23
|
2026-02-26 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2026-04-20 | Spain | Acceptable 2026-05-29
|
2026-06-01 |