Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ended
Participants planned
106
Countries
1
Sites
4
Advanced solid tumours
Key facts
- Sponsor
- Repare Therapeutics USA Inc.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- completed 12 Feb 2025
- Decision date (initial)
- 2024-04-24
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2024-511927-32-00
- EudraCT number
- 2021-006582-38
- ClinicalTrials.gov
- NCT05147350
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Advanced solid tumours
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Repare Therapeutics USA Inc.
- Sponsor organisation
- Repare Therapeutics USA Inc.
- Address
- 101 Main Street Suite 1650
- City
- Cambridge
- Postcode
- 02142-1519
- Country
- United States
Scientific contact point
- Organisation
- Repare Therapeutics USA Inc.
- Contact name
- Nathan Hawkey, MD, MBA
Public contact point
- Organisation
- Repare Therapeutics USA Inc.
- Contact name
- clinical Development
Locations
1 EU/EEA country · 4 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Spain | Ended | 26 | 4 |
| Rest of world
Canada, United States, United Kingdom
|
— | 80 | — |
Investigational sites
Hospital Universitari Vall D Hebron
Medical Oncology Department, Passeig De La Vall D'Hebron 119-129, 08035, Barcelona
Hospital Quironsalud Barcelona
Institute of Oncology Barcelona, Placa D'alfonso Comin 5-7, 08023, Barcelona
Hospital Universitario Fundacion Jimenez Diaz
START - Madrid -FJD, Avenida De Los Reyes Catolicos 2, 28040, Madrid
Hospital Universitario Hm Sanchinarro
Centro Integral Oncológico Clara Campal (CIOCC), Calle Ona 10, 28050, Madrid
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-04-15 | Spain | Acceptable 2024-04-24
|
2024-04-24 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-07-11 | Spain | Acceptable 2024-09-09
|
2024-09-09 |