Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ended
Participants planned
16
Countries
1
Sites
1
Desmoid tumor
Key facts
- Sponsor
- Springworks Therapeutics Inc.
- Participant type
- Healthy volunteers
- Age range
- 18-64 years
- Gender
- Male
- Therapeutic area
- Diseases [C] - Skin and Connective Tissue Diseases [C17]
- Trial duration
- 24 Oct 2025 → 28 Mar 2026
- Decision date (initial)
- 2025-10-22
- 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
Desmoid tumor
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 25.0 | LLT | 10049444 | Fibromatosis | 100000004864 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Springworks Therapeutics Inc.
- Sponsor organisation
- Springworks Therapeutics Inc.
- Address
- 100 Washington Boulevard
- City
- Stamford
- Postcode
- 06902-9302
- Country
- United States
Scientific contact point
- Organisation
- Springworks Therapeutics Inc.
- Contact name
- Shina Cheng
Public contact point
- Organisation
- Springworks Therapeutics Inc.
- Contact name
- Shina Cheng
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Netherlands | Ended | 16 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Pharmaceutical Research Associates Group B.V.
Program Management, Van Swietenlaan 6, 9728 NZ, Groningen
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 |
|---|---|---|---|---|---|
| Netherlands | 2025-10-24 | 2026-03-27 | 2025-10-27 | 2026-02-13 |
Application history
4 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-09-01 | Netherlands | Acceptable 2025-10-17
|
2025-10-22 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-10-29 | Netherlands | Acceptable 2025-11-06
|
2025-11-06 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-12-22 | Netherlands | Acceptable 2026-01-22
|
2026-01-23 |
| 4 | SUBSTANTIAL MODIFICATION | SM-3 | 2026-03-06 | Netherlands | Acceptable | 2026-03-12 |