Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Authorised, recruitment pending
Participants planned
103
Countries
1
Sites
5
Metastatic or advanced malignant solid tumors
Key facts
- Sponsor
- Genmab A/S
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Not possible to specify
- Decision date (initial)
- 2026-04-27
- 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
Metastatic or advanced malignant solid tumors
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Genmab A/S
- Sponsor organisation
- Genmab A/S
- Address
- Carl Jacobsens Vej 30
- City
- Valby
- Postcode
- 2500
- Country
- Denmark
Scientific contact point
- Organisation
- Genmab A/S
- Contact name
- Clinical Trial Information
Public contact point
- Organisation
- Genmab A/S
- Contact name
- Clinical Trial Information
Locations
1 EU/EEA country · 5 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Spain | Authorised, recruitment pending | 50 | 5 |
| Rest of world
Japan, United States
|
— | 53 | — |
Investigational sites
Hospital Universitario Quironsalud Madrid
NEXT Oncology, Calle De Diego De Velazquez 1, 28223, Pozuelo De Alarcon
Hospital Universitari Vall D Hebron
Oncology - Phase I, Passeig De La Vall D'Hebron 119-129, 08035, Barcelona
Hospital Hm Nou Delfos
START, Avinguda De Vallcarca 151, 08023, Barcelona
Hospital Universitario Fundacion Jimenez Diaz
START, Avenida De Los Reyes Catolicos 2, 28040, Madrid
Hospital Universitario Hm Sanchinarro
START, Calle Ona 10, 28050, Madrid
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2026-01-09 | Spain | Acceptable with conditions 2026-04-20
|
2026-04-27 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2026-04-30 | Spain | Acceptable 2026-05-19
|
2026-05-22 |