Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Authorised, recruiting
Participants planned
21
Countries
1
Sites
5
Advanced solid tumors (cutaneous melanoma, mucosal melanoma, cutaneous squamous cell carcinoma, Merkel cell carcinoma, or basal cell carcinoma)
Key facts
- Sponsor
- Kupando GmbH
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 27 Mar 2026 → ongoing
- Decision date (initial)
- 2025-11-12
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2025-522402-21-00
- WHO UTN
- U1111-1323-0949
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Advanced solid tumors (cutaneous melanoma, mucosal melanoma, cutaneous squamous cell carcinoma, Merkel cell carcinoma, or basal cell carcinoma)
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 26.0 | LLT | 10088049 | Cutaneous melanoma | 100000004848 |
| 20.0 | PT | 10004146 | Basal cell carcinoma | 100000004864 |
| 21.1 | PT | 10041834 | Squamous cell carcinoma of skin | 100000004864 |
| 21.1 | PT | 10029266 | Neuroendocrine carcinoma of the skin | 100000004864 |
| 28.0 | LLT | 10089510 | Mucosal melanoma | 100000004864 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Kupando GmbH
- Sponsor organisation
- Kupando GmbH
- Address
- Willy-Brandt-Platz 2
- City
- Schoenefeld
- Postcode
- 12529
- Country
- Germany
Scientific contact point
- Organisation
- Kupando GmbH
- Contact name
- Clinical Trials Division
Public contact point
- Organisation
- Kupando GmbH
- Contact name
- Clinical Trials Division
Locations
1 EU/EEA country · 5 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Germany | Authorised, recruiting | 21 | 5 |
| Rest of world | — | 0 | — |
Investigational sites
Universitaetsklinikum Koeln AöR
Klinik für Dermatologie und Venerologie, Kerpener Strasse 62, Lindenthal, Cologne
Universitaetsklinikum Wuerzburg AöR
Department of Dermatology, Josef-Schneider-Strasse 2, Grombuehl, Wuerzburg
St. Josef-Hospital
Department of Dermatology, Gudrunstrasse 56, Grumme, Bochum
Fachklinik Hornheide e.V.
Dermatologie, Dorbaumstrasse 300, Handorf, Muenster
LMU Klinikum Muenchen AöR
Klinik und Poliklinik für Dermatologie und Allergologie, Frauenlobstrasse 9-11, Ludwigsvorstadt-Isarvorstadt, Munich
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 | 2026-03-27 |
Application history
4 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-09-18 | Germany | Acceptable 2025-11-05
|
2025-11-12 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-12-19 | Germany | Acceptable 2026-01-06
|
2026-01-06 |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2026-02-10 | Germany | Acceptable 2026-01-06
|
2026-02-10 |
| 4 | SUBSTANTIAL MODIFICATION | SM-2 | 2026-03-27 | Germany | Acceptable | 2026-04-20 |