Overview
Sponsor-declared trial summary
Phase
Phase I and Phase II (Integrated) - First administration to humans
Status
Ended
Participants planned
86
Countries
1
Sites
3
Solid tumors
Key facts
- Sponsor
- Replimune Group Inc.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 12 Jul 2022 → 16 May 2026
- Decision date (initial)
- 2024-05-08
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2024-512866-32-00
- EudraCT number
- 2018-003765-33
- ClinicalTrials.gov
- NCT04336241
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
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
Replimune Group Inc.
- Sponsor organisation
- Replimune Group Inc.
- Address
- 500 Unicorn Park Drive Floor Third
- City
- Woburn
- Postcode
- 01801-3377
- Country
- United States
Scientific contact point
- Organisation
- Replimune Group Inc.
- Contact name
- Kari Jeschke, SVP Regulatory Affairs
Public contact point
- Organisation
- Replimune Group Inc.
- Contact name
- Kari Jeschke, SVP Regulatory Affairs
Locations
1 EU/EEA country · 3 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Spain | Ended | 32 | 3 |
| Rest of world
United Kingdom
|
— | 54 | — |
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 | 2022-07-12 | 2022-09-15 | 2024-02-05 |
Application history
6 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-05-02 | Spain | Acceptable 2024-05-08
|
2024-05-08 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2024-06-24 | Spain | Acceptable 2024-05-08
|
2024-06-24 |
| 3 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-09-23 | Spain | Acceptable 2024-10-22
|
2024-10-22 |
| 4 | SUBSTANTIAL MODIFICATION | SM-3 | 2025-04-24 | Spain | Acceptable 2025-06-05
|
2025-06-12 |
| 5 | SUBSTANTIAL MODIFICATION | SM-4 | 2025-10-10 | Spain | Acceptable 2025-12-12
|
2025-12-17 |
| 6 | SUBSTANTIAL MODIFICATION | SM-5 | 2026-02-20 | Spain | Acceptable 2026-04-06
|
2026-04-09 |