Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ended
Participants planned
18
Countries
1
Sites
2
Locally advanced (unresectable) or metastatic soft tissue sarcoma
Key facts
- Sponsor
- Thermosome GmbH
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 3 Apr 2023 → 28 May 2025
- Decision date (initial)
- 2024-09-20
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- Yes
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2023-507836-19-00
- EudraCT number
- 2020-005033-32
- ClinicalTrials.gov
- NCT05858710
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Locally advanced (unresectable) or metastatic soft tissue sarcoma
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Thermosome GmbH
- Sponsor organisation
- Thermosome GmbH
- Address
- Am Klopferspitz 19, Martinsried Martinsried
- City
- Planegg
- Postcode
- 82152
- Country
- Germany
Scientific contact point
- Organisation
- Thermosome GmbH
- Contact name
- Clinical Development
Public contact point
- Organisation
- Thermosome GmbH
- Contact name
- Clinical Development
Locations
1 EU/EEA country · 2 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Germany | Ended | 18 | 2 |
| Rest of world | — | 0 | — |
Investigational sites
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 |
|---|---|---|---|---|---|
| Germany | 2023-04-03 | 2025-05-28 | 2023-04-03 | 2025-02-05 |
Application history
3 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-09-06 | Germany | Acceptable 2024-09-12
|
2024-09-20 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-10-18 | Germany | Acceptable 2024-11-08
|
2024-11-11 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-05-19 | Germany | Acceptable 2025-07-17
|
2025-07-17 |