Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Authorised, recruitment pending
Participants planned
100
Countries
1
Sites
5
Adenoid cystic carcinoma (ACC)
Key facts
- Sponsor
- Remix Therapeutics Inc.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Decision date (initial)
- 2024-05-06
- 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
Adenoid cystic carcinoma (ACC)
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.0 | PT | 10053231 | Adenoid cystic carcinoma | 100000004864 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Remix Therapeutics Inc.
- Sponsor organisation
- Remix Therapeutics Inc.
- Address
- 100 Forge Road Suite 400
- City
- Watertown
- Postcode
- 02472-2265
- Country
- United States
Scientific contact point
- Organisation
- Remix Therapeutics Inc.
- Contact name
- Jennifer Webster
Public contact point
- Organisation
- Remix Therapeutics Inc.
- Contact name
- Jennifer Webster
Locations
1 EU/EEA country · 5 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Authorised, recruitment pending | 30 | 5 |
| Rest of world
United States
|
— | 70 | — |
Investigational sites
Institut Gustave Roussy
Cancérologie Cervico-Faciale, 114 Rue Edouard Vaillant, 94800, Villejuif
Centre Hospitalier Universitaire De Bordeaux
Oncologie Médicale, 1 Rue Jean Burguet, 33000, Bordeaux
Institut De Cancerologie De L Ouest
Oncologie Médicale, Bd Du Professeur Jacques Monod, 44800, St Herblain
Centre Antoine Lacassagne
Unité de Phase Précoce, 33 Avenue De Valombrose, 06189, Nice Cedex 2
Centre Leon Berard
Oncologie Médicale, 28 Rue Laennec, 69008, Lyon
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 |
Application history
8 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-01-29 | France | Acceptable with conditions 2024-04-29
|
2024-05-06 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-01-15 | France | Acceptable 2025-02-14
|
2025-02-26 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-03-18 | France | Acceptable 2025-05-14
|
2025-05-14 |
| 4 | SUBSTANTIAL MODIFICATION | SM-3 | 2025-05-14 | France | Acceptable 2025-07-15
|
2025-07-15 |
| 5 | SUBSTANTIAL MODIFICATION | SM-4 | 2025-07-29 | France | Acceptable 2025-08-29
|
2025-08-29 |
| 6 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-11-26 | France | Acceptable 2025-08-29
|
2025-11-26 |
| 7 | SUBSTANTIAL MODIFICATION | SM-6 | 2026-02-12 | France | Acceptable with conditions 2026-04-17
|
2026-04-17 |
| 8 | SUBSTANTIAL MODIFICATION | SM-7 | 2026-04-24 | France | Acceptable with conditions | 2026-05-13 |