Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ongoing, recruiting
Participants planned
145
Countries
1
Sites
2
Advanced Solid Tumors
Key facts
- Sponsor
- Innate Pharma
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 25 Apr 2025 → ongoing
- Decision date (initial)
- 2025-03-13
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2024-519162-46-00
- ClinicalTrials.gov
- NCT06781983
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
Innate Pharma
- Sponsor organisation
- Innate Pharma
- Address
- 117 Avenue De Luminy
- City
- Marseille
- Postcode
- 13009
- Country
- France
Scientific contact point
- Organisation
- Innate Pharma
- Contact name
- Markus Jensen
Public contact point
- Organisation
- Innate Pharma
- Contact name
- Markus Jensen
Locations
1 EU/EEA country · 2 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Ongoing, recruiting | 22 | 2 |
| Rest of world
United States
|
— | 123 | — |
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 | 2025-04-25 | 2025-07-11 |
Application history
3 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-11-27 | France | Acceptable 2025-03-13
|
2025-03-13 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-09-19 | France | Acceptable 2025-10-13
|
2025-10-30 |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2026-01-15 | France | Acceptable 2025-10-13
|
2026-01-15 |