Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ongoing, recruiting
Participants planned
134
Countries
4
Sites
7
Advanced solid tumors
Key facts
- Sponsor
- Nimbus Wadjet Inc.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 24 Oct 2025 → ongoing
- Decision date (initial)
- 2025-09-15
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2025-522774-36-00
- ClinicalTrials.gov
- NCT06898450
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Advanced solid tumors
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 28.0 | SOC | 10029104 | Neoplasms benign malignant and unspecified (incl cysts and polyps) | 2 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Nimbus Wadjet Inc.
- Sponsor organisation
- Nimbus Wadjet Inc.
- Address
- 22 Boston Wharf Road Floor 9
- City
- Boston
- Postcode
- 02210-3032
- Country
- United States
Scientific contact point
- Organisation
- Nimbus Wadjet Inc.
- Contact name
- Claudia Fehling, Regulatory Lead
Public contact point
- Organisation
- Nimbus Wadjet Inc.
- Contact name
- Sean Rossi, Executive Director, Clinical Operations
Locations
4 EU/EEA countries · 7 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Ongoing, recruiting | 26 | 3 |
| Ireland | Ongoing, recruiting | 8 | 1 |
| Portugal | Ongoing, recruiting | 10 | 1 |
| Spain | Ongoing, recruiting | 10 | 2 |
| Rest of world
United Kingdom, Australia, United States
|
— | 80 | — |
Investigational sites
Institut Paoli Calmettes
-, 232 Boulevard De Sainte Marguerite, Bp 156, Marseille
Assistance Publique Hopitaux De Paris
Service d’oncologie médicale, 184 Rue Du Faubourg Saint Antoine, 75012, Paris
Centre Hospitalier Universitaire De Poitiers
Pole régionale de cancérologie Service d'Oncologie Médicale, 2 Rue De La Miletrie, 86000, Poitiers
Start Research Portugal Unipessoal Lda.
Medical Oncology, Rua Castilho 39 8º E, 1250-068, Lisbon
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 | 2025-10-29 | 2025-11-12 | |||
| Ireland | 2025-12-22 | 2026-01-20 | |||
| Portugal | 2025-10-24 | 2025-11-06 | |||
| Spain | 2025-10-29 | 2025-11-07 |
Application history
3 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-06-20 | France | Acceptable 2025-09-15
|
2025-09-15 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-10-17 | France | Acceptable 2025-09-15
|
2025-10-17 |
| 3 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-12-15 | France | Acceptable 2026-02-27
|
2026-02-27 |