Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ended
Participants planned
82
Countries
3
Sites
7
Advanced 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
- 22 Nov 2022 → 15 May 2026
- Decision date (initial)
- 2024-12-06
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2024-512710-17-00
- EudraCT number
- 2020-002870-29
- ClinicalTrials.gov
- NCT04336241
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Advanced 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
3 EU/EEA countries · 7 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Ended | 5 | 1 |
| Greece | Ended | 11 | 2 |
| Spain | Ended | 20 | 4 |
| Rest of world
United States, United Kingdom
|
— | 46 | — |
Investigational sites
Institut Gustave Roussy
Département d'Innovation Thérapeutique et des Essais Précoces (DITEP), 114 Rue Edouard Vaillant, 94800, Villejuif
Laiko General Hospital Of Athens
1st Department of Internal Medicine, Sevastoupoleos 16, 115 26, Athens
University General Hospital Attikon
2nd Propaedeutic Internal Medicine Department , Oncology Clinic, Rimini Street 1, 124 62, Athens
Hospital Universitario Hm Sanchinarro
Oncology, Calle Ona 10, 28050, Madrid
Hospital Clinico Universitario De Valencia
Oncology, Avenida Blasco Ibanez 17, 46010, Valencia
Hospital Universitari Vall D Hebron
Oncology, Passeig De La Vall D'Hebron 119-129, 08035, Barcelona
Hospital Clinic De Barcelona
Oncology, Calle Villarroel 170, 08036, Barcelona
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 | 2023-02-22 | 2025-12-18 | 2023-03-02 | 2023-06-01 | |
| Greece | 2022-12-02 | 2026-03-20 | 2023-01-17 | 2023-05-23 | |
| Spain | 2022-11-22 | 2025-12-18 | 2022-11-28 | 2023-11-22 |
Application history
6 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-09-30 | Spain | Acceptable 2024-12-02
|
2024-12-02 |
| 2 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-04-11 | Spain | Acceptable 2025-06-11
|
2025-06-11 |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-07-25 | Acceptable 2025-06-11
|
2025-07-25 | |
| 4 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2025-08-22 | Spain | Acceptable 2025-06-11
|
2025-08-22 |
| 5 | NON SUBSTANTIAL MODIFICATION | NSM-3 | 2025-10-07 | Spain | Acceptable 2025-06-11
|
2025-10-07 |
| 6 | NON SUBSTANTIAL MODIFICATION | NSM-4 | 2026-02-23 | Spain | Acceptable 2025-06-11
|
2026-02-23 |