Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ended
Participants planned
26
Countries
1
Sites
5
Advanced 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
- 4 Nov 2022 → 23 Oct 2025
- Decision date (initial)
- 2024-10-02
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2024-514357-29-00
- EudraCT number
- 2022-001003-40
- ClinicalTrials.gov
- NCT05586321
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Advanced solid tumors
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | LLT | 10065147 | Malignant solid tumor | 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 · 5 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Spain | Ended | 18 | 5 |
| Rest of world
Georgia, Moldova, Republic of
|
— | 8 | — |
Investigational sites
Hospital Universitari Vall D Hebron
Oncology Department, Passeig De La Vall D'Hebron 119-129, 08035, Barcelona
Hospital Universitario Fundacion Jimenez Diaz
Research Facility, Avenida De Los Reyes Catolicos 2, 28040, Madrid
MD Anderson Cancer Center
Research Facility, Calle De Arturo Soria Nº 270, 28033, Madrid
Clinica Universidad De Navarra
Research Facility, Pio XII Etorbidea 36, 31008, Pamplona
Hospital Universitario Hm Sanchinarro
Oncology, Calle Ona 10, 28050, Madrid
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 | 2022-11-04 | 2025-10-23 | 2022-11-22 | 2023-11-02 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-09-25 | Spain | Acceptable 2024-10-02
|
2024-10-02 |