Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ended
Participants planned
132
Countries
1
Sites
4
Advanced Solid Tumors
Key facts
- Sponsor
- ADC Therapeutics S.A.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 23 Dec 2022 → 10 Sep 2024
- Decision date (initial)
- 2022-07-18
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
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
ADC Therapeutics S.A.
- Sponsor organisation
- ADC Therapeutics S.A.
- Address
- Route De La Corniche 3b
- City
- Epalinges
- Postcode
- 1066
- Country
- Switzerland
Scientific contact point
- Organisation
- ADC Therapeutics S.A.
- Contact name
- Clinical Operations
Public contact point
- Organisation
- ADC Therapeutics S.A.
- Contact name
- Clinical Operations
Locations
1 EU/EEA country · 4 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Spain | Ended | 50 | 4 |
| Rest of world
United Kingdom, United States
|
— | 82 | — |
Investigational sites
Bellvitge University Hospital
Oncology, Carretera De La Feixa Llarga S/n, Poligono Industrial De La Zona Ranca De Barcelona, L'hospitalet De Llobregat
Hospital Universitari Vall D Hebron
Oncology, Passeig De La Vall D Hebron 119-129, 08035, Barcelona
Hospital Universitario 12 De Octubre
Oncology, Bloque D, Avenida De Cordoba S/n, Madrid
Hospital Universitario Fundación Jiménez Díaz
Oncology, Avenida De Los Reyes Catolicos 2, 28040, 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 | 2022-12-23 | 2023-01-30 | 2024-01-03 |
Application history
5 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2022-04-05 | Spain | Acceptable with conditions 2022-07-13
|
2022-07-18 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2022-08-17 | Spain | Acceptable 2022-09-29
|
2022-09-29 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2022-10-03 | Spain | Acceptable | 2022-11-08 |
| 4 | SUBSTANTIAL MODIFICATION | SM-4 | 2023-08-24 | Spain | Acceptable 2023-10-05
|
2023-10-23 |
| 5 | SUBSTANTIAL MODIFICATION | SM-5 | 2023-11-03 | Spain | 2023-12-18 |