Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ended
Participants planned
45
Countries
1
Sites
2
small cell lung cancer, non-smallcell lung cancer, colorectal cancer, breast cancer, Pancreatic cancer and gastric cancer
Key facts
- Sponsor
- Fusion Pharmaceuticals Inc.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- completed 24 Jul 2025
- Decision date (initial)
- 2025-07-15
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
small cell lung cancer, non-smallcell lung cancer, colorectal cancer, breast cancer, Pancreatic cancer and gastric cancer
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.0 | PT | 10061451 | Colorectal cancer | 100000004864 |
| 27.1 | PT | 10061873 | Non-small cell lung cancer | 100000004864 |
| 21.1 | PT | 10041067 | Small cell lung cancer | 100000004864 |
| 20.0 | PT | 10075566 | Triple negative breast cancer | 100000004864 |
| 21.1 | PT | 10017758 | Gastric cancer | 100000004864 |
| 23.0 | PT | 10065430 | HER2 positive breast cancer | 100000004864 |
| 21.0 | LLT | 10033604 | Pancreatic cancer | 10029104 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Fusion Pharmaceuticals Inc.
- Sponsor organisation
- Fusion Pharmaceuticals Inc.
- Address
- 270 Longwood Road South
- City
- Hamilton
- Postcode
- L8P 0A6
- Country
- Canada
Scientific contact point
- Organisation
- Fusion Pharmaceuticals Inc.
- Contact name
- Stephanie Allen
Public contact point
- Organisation
- Fusion Pharmaceuticals Inc.
- Contact name
- Chris Leamon
Locations
1 EU/EEA country · 2 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Netherlands | Ended | 45 | 2 |
| Rest of world | — | 0 | — |
Investigational sites
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-05-02 | Netherlands | Acceptable 2025-07-15
|
2025-07-15 |