Overview
Sponsor-declared trial summary
Phase
Phase I and Phase II (Integrated) - First administration to humans
Status
Ended
Participants planned
180
Countries
1
Sites
1
Advanced solid tumors
Key facts
- Sponsor
- Centessa Pharmaceuticals UK Limited
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 3 Jan 2024 → 9 Sep 2025
- Decision date (initial)
- 2023-11-20
- 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 | LLT | 10065252 | Solid tumor | 10029104 |
| 21.1 | LLT | 10065147 | Malignant solid tumor | 10029104 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Centessa Pharmaceuticals UK Limited
- Sponsor organisation
- Centessa Pharmaceuticals UK Limited
- Address
- 3rd Floor, 1 Ashley Road 1 Ashley Road
- City
- Altrincham
- Postcode
- WA14 2DT
- Country
- United Kingdom
Scientific contact point
- Organisation
- Centessa Pharmaceuticals UK Limited
- Contact name
- SVP, Clinical Development, Innovative Medicines
Public contact point
- Organisation
- Centessa Pharmaceuticals UK Limited
- Contact name
- SVP, Clinical Development, Innovative Medicines
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Ended | 6 | 1 |
| Rest of world
United States
|
— | 174 | — |
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 |
|---|---|---|---|---|---|
| France | 2024-01-03 | 2024-01-03 |
Application history
4 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-07-24 | France | Acceptable 2023-11-13
|
2023-11-20 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2023-12-21 | France | Acceptable 2024-03-25
|
2024-03-25 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2024-04-05 | France | Acceptable | 2024-05-14 |
| 4 | SUBSTANTIAL MODIFICATION | SM-4 | 2024-05-28 | France | Acceptable 2024-06-26
|
2024-07-15 |