Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ongoing, recruiting
Participants planned
90
Countries
1
Sites
1
Patients with Advanced Solid Malignancies
Key facts
- Sponsor
- Nectin Therapeutics Ltd.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Not possible to specify
- Trial duration
- 15 Sep 2025 → ongoing
- Decision date (initial)
- 2025-07-07
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2024-520077-12-00
- ClinicalTrials.gov
- NCT05378425
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Patients with Advanced Solid Malignancies
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Nectin Therapeutics Ltd.
- Sponsor organisation
- Nectin Therapeutics Ltd.
- Address
- Hi-Tech Compound In Givat Ram Campus
- City
- Jerusalem
- Postcode
- 9139002
- Country
- Israel
Scientific contact point
- Organisation
- Nectin Therapeutics Ltd.
- Contact name
- Chief Development Officer
Public contact point
- Organisation
- Nectin Therapeutics Ltd.
- Contact name
- Chief Development Officer
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Poland | Ongoing, recruiting | 10 | 1 |
| Rest of world
Israel, United States
|
— | 80 | — |
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 |
|---|---|---|---|---|---|
| Poland | 2025-09-15 | 2025-10-29 |
Application history
5 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-03-14 | Poland | Acceptable with conditions 2025-06-30
|
2025-07-07 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-07-09 | Poland | Acceptable 2025-08-25
|
2025-08-29 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-10-30 | Poland | Acceptable | 2025-12-10 |
| 4 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-12-10 | Poland | Acceptable | 2025-12-10 |
| 5 | SUBSTANTIAL MODIFICATION | SM-3 | 2026-04-21 | Poland | Acceptable 2026-05-27
|
2026-05-31 |