Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ended
Participants planned
45
Countries
1
Sites
2
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
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 20 Mar 2025 → 8 Apr 2026
- Decision date (initial)
- 2024-09-11
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2024-513563-75-00
- ClinicalTrials.gov
- NCT06573294
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Metastatic or advanced malignant solid tumors
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.0 | LLT | 10049280 | Solid tumour | 10029104 |
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
- Genmab Trial Information
Public contact point
- Organisation
- Genmab A/S
- Contact name
- Genmab Trial Information
Locations
1 EU/EEA country · 2 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Spain | Ended | 18 | 2 |
| Rest of world
Japan, United States
|
— | 27 | — |
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 |
|---|---|---|---|---|---|
| Spain | 2025-03-20 | 2025-03-20 |
Application history
6 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-06-14 | Spain | Acceptable 2024-09-11
|
2024-09-11 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-11-18 | Spain | Acceptable 2025-01-21
|
2025-02-21 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-04-17 | Spain | Acceptable 2025-05-22
|
2025-06-04 |
| 4 | SUBSTANTIAL MODIFICATION | SM-3 | 2025-07-22 | Spain | Acceptable | 2025-09-01 |
| 5 | SUBSTANTIAL MODIFICATION | SM-4 | 2025-10-03 | Spain | Acceptable 2025-10-30
|
2025-11-03 |
| 6 | SUBSTANTIAL MODIFICATION | SM-5 | 2025-12-11 | Spain | Acceptable 2026-02-23
|
2026-02-24 |