Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Authorised, recruitment pending
Participants planned
58
Countries
1
Sites
2
Advanced Solid Tumors
Key facts
- Sponsor
- Merck Healthcare KGaA
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Decision date (initial)
- 2026-03-03
- 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 |
|---|---|---|---|---|
| 27.1 | PT | 10061873 | Non-small cell lung cancer | 100000004864 |
| 20.0 | PT | 10075566 | Triple negative breast cancer | 100000004864 |
| 20.0 | PT | 10073364 | Ductal adenocarcinoma of pancreas | 100000004864 |
| 21.1 | PT | 10017758 | Gastric cancer | 100000004864 |
| 20.0 | PT | 10061328 | Ovarian epithelial cancer | 100000004864 |
| 26.1 | PT | 10060121 | Squamous cell carcinoma of head and neck | 100000004864 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Merck Healthcare KGaA
- Sponsor organisation
- Merck Healthcare KGaA
- Address
- Frankfurter Strasse 250
- City
- Darmstadt
- Postcode
- 64293
- Country
- Germany
Scientific contact point
- Organisation
- Merck Healthcare KGaA
- Contact name
- Global Regulatory Affairs
Public contact point
- Organisation
- Merck Healthcare KGaA
- Contact name
- Global Regulatory Affairs
Locations
1 EU/EEA country · 2 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Spain | Authorised, recruitment pending | 14 | 2 |
| Rest of world
Canada, Japan, United States
|
— | 44 | — |
Investigational sites
Hospital Universitario Quironsalud Madrid
Oncology, Calle De Diego De Velazquez 1, 28223, Pozuelo De Alarcon
Hospital Universitari Vall D Hebron
Oncology, Passeig De La Vall D'Hebron 119-129, 08035, Barcelona
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-11-17 | Spain | Acceptable 2026-02-27
|
2026-03-03 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2026-03-13 | Spain | Acceptable 2026-02-27
|
2026-03-13 |