Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ended
Participants planned
130
Countries
1
Sites
1
Advanced Solid Tumors
Key facts
- Sponsor
- Dragonfly Therapeutics Inc.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 26 Apr 2024 → 26 Nov 2025
- Decision date (initial)
- 2024-04-05
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2023-507320-23-00
- ClinicalTrials.gov
- NCT06108479
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Advanced Solid Tumors
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | LLT | 10065252 | Solid tumor | 10029104 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Dragonfly Therapeutics Inc.
- Sponsor organisation
- Dragonfly Therapeutics Inc.
- Address
- 35 Gatehouse Drive
- City
- Waltham
- Postcode
- 02451-1215
- Country
- United States
Scientific contact point
- Organisation
- Dragonfly Therapeutics Inc.
- Contact name
- Sean Rossi
Public contact point
- Organisation
- Dragonfly Therapeutics Inc.
- Contact name
- Sean Rossi
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Ended | 28 | 1 |
| Rest of world
Australia, United States
|
— | 102 | — |
Investigational sites
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 | 2024-04-26 | 2025-09-08 | 2024-05-29 | 2025-02-18 |
Application history
3 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-11-27 | France | Acceptable 2024-04-01
|
2024-04-05 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-05-14 | France | Acceptable 2024-04-01
|
2025-05-14 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-06-13 | France | Acceptable 2025-08-01
|
2025-08-01 |