Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Authorised, recruiting
Participants planned
70
Countries
2
Sites
9
Solid tumors and ovarian cancer
Key facts
- Sponsor
- Step Pharma
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 18 Apr 2025 → ongoing
- Decision date (initial)
- 2024-11-19
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2024-512375-12-00
- ClinicalTrials.gov
- NCT06297525
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Solid tumors and ovarian cancer
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | LLT | 10065252 | Solid tumor | 10029104 |
| 21.1 | LLT | 10033131 | Ovarian carcinoma | 10029104 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Step Pharma
- Sponsor organisation
- Step Pharma
- Address
- 101 Rue De Sevres
- City
- Paris
- Postcode
- 75006
- Country
- France
Scientific contact point
- Organisation
- Step Pharma
- Contact name
- VP, Head of Clinical Operations
Public contact point
- Organisation
- Step Pharma
- Contact name
- VP, Head of Clinical Operations
Locations
2 EU/EEA countries · 9 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Ongoing, recruiting | 10 | 4 |
| Spain | Authorised, recruitment pending | 10 | 5 |
| Rest of world
United Kingdom, United States
|
— | 50 | — |
Investigational sites
Institut Bergonie
Département d’oncologie médicale, 180 R De Saint Genes, 229 Cours De L Argonne, Bordeaux
Centre Antoine Lacassagne
Service d’oncologie, 33 Avenue De Valombrose, 06189, Nice Cedex 2
Institut Gustave Roussy
DITEP (Département d’Innovation Thérapeutique et d’Essais Précoces), 114 Rue Edouard Vaillant, 94800, Villejuif
Centre De Lutte Contre Le Cancer Eugene Marquis
Service de Gynécologie oncologie, Avenue La Bataille Flandre Dunkerque, Cs 44229, Rennes Cedex
Hospital Clinico Universitario De Valencia
Medical Oncology, Avenida Blasco Ibanez 17, 46010, Valencia
Hospital Universitari Vall D Hebron
Medical Oncology, Passeig De La Vall D'Hebron 119-129, 08035, Barcelona
Hospital Universitario Hm Sanchinarro
Centro Integral Oncologico Clara Campal, Calle Ona 10, 28050, Madrid
Clinica Universidad De Navarra
Medical Oncology, Calle Marquesado De Santa Marta 1, 28027, Madrid
University Hospital Virgen Del Rocio S.L.
Medical Oncology, Avenida De Manuel Siurot S/n, 41013, Sevilla
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 | 2025-04-18 | 2025-04-18 |
Application history
10 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-08-02 | Spain | Acceptable 2024-11-18
|
2024-11-18 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-11-28 | Spain | Acceptable 2025-01-23
|
2025-01-23 |
| 3 | SUBSTANTIAL MODIFICATION | SM-3 | 2025-03-27 | Spain | Acceptable | 2025-04-10 |
| 4 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2025-04-11 | Spain | 2025-04-11 | |
| 5 | NON SUBSTANTIAL MODIFICATION | NSM-3 | 2025-05-12 | Spain | 2025-05-12 | |
| 6 | NON SUBSTANTIAL MODIFICATION | NSM-4 | 2025-08-13 | 2025-08-13 | ||
| 7 | SUBSTANTIAL MODIFICATION | SM-4 | 2025-08-19 | Spain | Acceptable 2025-11-18
|
2025-11-19 |
| 8 | NON SUBSTANTIAL MODIFICATION | NSM-5 | 2025-12-08 | Spain | Acceptable 2025-11-18
|
2025-12-08 |
| 9 | SUBSTANTIAL MODIFICATION | SM-6 | 2025-12-09 | Spain | Acceptable 2026-03-16
|
2026-03-17 |
| 10 | NON SUBSTANTIAL MODIFICATION | NSM-6 | 2026-05-07 | Spain | Acceptable 2026-03-16
|
2026-05-07 |