Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ongoing, recruitment ended
Participants planned
80
Countries
1
Sites
3
Advanced Solid Tumors
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]
- Trial duration
- 7 Nov 2023 → ongoing
- Decision date (initial)
- 2023-09-27
- 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 Solid Tumors
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | LLT | 10065252 | Solid tumor | 10029104 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Tolremo Therapeutics AG
- Sponsor organisation
- Tolremo Therapeutics AG
- Address
- Hochbergerstrasse 60c
- City
- Basel Town
- 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 | Ongoing, recruitment ended | 40 | 3 |
| Rest of world
Switzerland, United States
|
— | 40 | — |
Investigational sites
Hospital Universitario Quironsalud Madrid
Oncology, Calle De Diego De Velazquez 1, 28223, Pozuelo De Alarcon
Hospital Quironsalud Barcelona
Oncology, Placa D'alfonso Comin 5-7, 08023, Barcelona
Hospital Universitari Vall D Hebron
Oncology, Edificio Materno-Infantil, Passeig De La Vall D'hebron 119-129, Barcelona
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 | 2023-11-07 | 2023-11-07 | 2026-03-25 |
Application history
6 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-06-23 | Spain | Acceptable 2023-09-27
|
2023-09-27 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-06-13 | Spain | Acceptable 2024-08-27
|
2024-08-27 |
| 3 | SUBSTANTIAL MODIFICATION | SM-4 | 2024-10-10 | Spain | Acceptable 2024-11-25
|
2024-11-25 |
| 4 | SUBSTANTIAL MODIFICATION | SM-5 | 2025-02-28 | Spain | Acceptable 2025-04-14
|
2025-04-16 |
| 5 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-10-21 | Spain | Acceptable 2025-04-14
|
2025-10-21 |
| 6 | SUBSTANTIAL MODIFICATION | SM-6 | 2025-12-16 | Spain | Acceptable 2026-02-05
|
2026-02-10 |