Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ended
Participants planned
260
Countries
2
Sites
7
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
- 9 Jan 2023 → 18 Apr 2025
- Decision date (initial)
- 2022-07-28
- 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 |
|---|---|---|---|---|
| 21.1 | PT | 10061873 | Non-small cell lung cancer | 100000004864 |
| 21.1 | LLT | 10051971 | Pancreatic adenocarcinoma | 10029104 |
| 20.0 | HLT | 10039498 | Bone sarcomas | 10029104 |
| 21.1 | LLT | 10065147 | Malignant solid tumor | 10029104 |
| 15.1 | HLGT | 10041299 | Soft tissue sarcomas | 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
2 EU/EEA countries · 7 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Ended | 75 | 4 |
| Spain | Ended | 60 | 3 |
| Rest of world
United States, United Kingdom
|
— | 125 | — |
Investigational sites
Centre Antoine Lacassagne
Oncology, 33 Avenue De Valombrose, 06189, Nice Cedex 2
Institut Bergonie
Oncology, 229 Cours De L Argonne, 33000, Bordeaux
Centre Leon Berard
Oncology, 28 Rue Laennec, 69008, Lyon
Institut Curie Hospital
Oncology, 26 Rue D Ulm, 75005, Paris
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 |
|---|---|---|---|---|---|
| France | 2023-02-15 | 2023-06-15 | 2024-11-06 | ||
| Spain | 2023-01-09 | 2023-06-16 | 2024-11-06 |
Application history
14 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2022-04-22 | Spain | Acceptable with conditions 2022-07-26
|
2022-07-28 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2022-08-08 | Spain | Acceptable with conditions 2022-07-26
|
2022-08-08 |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2022-08-31 | Acceptable with conditions 2022-07-26
|
2022-08-31 | |
| 4 | SUBSTANTIAL MODIFICATION | SM-1 | 2022-09-09 | Spain | Acceptable with conditions | 2022-10-18 |
| 5 | SUBSTANTIAL MODIFICATION | SM-2 | 2022-10-06 | Acceptable with conditions | 2022-10-13 | |
| 6 | SUBSTANTIAL MODIFICATION | SM-3 | 2023-01-16 | Spain | Acceptable 2023-04-17
|
2023-04-21 |
| 7 | NON SUBSTANTIAL MODIFICATION | NSM-3 | 2023-04-26 | Spain | Acceptable 2023-04-17
|
2023-04-26 |
| 8 | NON SUBSTANTIAL MODIFICATION | NSM-4 | 2023-05-04 | Acceptable 2023-04-17
|
2023-05-04 | |
| 9 | SUBSTANTIAL MODIFICATION | SM-6 | 2023-06-01 | Acceptable | 2023-06-26 | |
| 10 | SUBSTANTIAL MODIFICATION | SM-7 | 2023-07-14 | Spain | Acceptable 2023-09-04
|
2023-09-08 |
| 11 | SUBSTANTIAL MODIFICATION | SM-8 | 2024-01-30 | Spain | Acceptable 2024-04-04
|
2024-04-04 |
| 12 | NON SUBSTANTIAL MODIFICATION | NSM-5 | 2024-05-17 | Spain | Acceptable 2024-04-04
|
2024-05-17 |
| 13 | NON SUBSTANTIAL MODIFICATION | NSM-6 | 2024-08-20 | Acceptable 2024-04-04
|
2024-08-20 | |
| 14 | NON SUBSTANTIAL MODIFICATION | NSM-8 | 2025-01-31 | Spain | Acceptable 2024-04-04
|
2025-01-31 |