Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ongoing, recruiting
Participants planned
205
Countries
1
Sites
3
Locally Advanced or Metastatic Solid Tumors
Key facts
- Sponsor
- Adcytherix
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Not possible to specify
- Trial duration
- 17 Mar 2026 → ongoing
- Decision date (initial)
- 2026-02-23
- 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
Locally Advanced or Metastatic 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
Adcytherix
- Sponsor organisation
- Adcytherix
- Address
- 4 Rue Leon Paulet
- City
- Marseille 8e Arrondissement
- Postcode
- 13008
- Country
- France
Scientific contact point
- Organisation
- Adcytherix
- Contact name
- clinicaltrials@adcytherix
Public contact point
- Organisation
- Adcytherix
- Contact name
- clinicaltrials@adcytherix
Locations
1 EU/EEA country · 3 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Spain | Ongoing, recruiting | 55 | 3 |
| Rest of world
Korea, Republic of, Australia, United States
|
— | 150 | — |
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 |
|---|---|---|---|---|---|
| Spain | 2026-03-17 | 2026-04-23 |
Application history
4 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-11-17 | Spain | Acceptable with conditions 2026-02-23
|
2026-02-23 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2026-03-18 | Spain | Acceptable with conditions 2026-02-23
|
2026-03-18 |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2026-03-19 | Spain | Acceptable with conditions 2026-02-23
|
2026-03-19 |
| 4 | SUBSTANTIAL MODIFICATION | SM-1 | 2026-04-17 | Spain | Acceptable 2026-05-30
|
2026-06-01 |