Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ongoing, recruiting
Participants planned
130
Countries
4
Sites
18
Advanced solid tumors
Key facts
- Sponsor
- Sairopa B.V.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 20 Aug 2024 → ongoing
- Decision date (initial)
- 2023-07-31
- 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
Advanced solid tumors
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.0 | LLT | 10048683 | Advanced cancer | 10029104 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Sairopa B.V.
- Sponsor organisation
- Sairopa B.V.
- Address
- Stationsplein 45, Unit A4.004 Unit A4.004
- City
- Rotterdam
- Postcode
- 3013 AK
- Country
- Netherlands
Scientific contact point
- Organisation
- Sairopa B.V.
- Contact name
- Clinical Project Director
Public contact point
- Organisation
- Sairopa B.V.
- Contact name
- Clinical Project Director
Locations
4 EU/EEA countries · 18 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Belgium | Ongoing, recruiting | 18 | 4 |
| France | Ongoing, recruiting | 25 | 7 |
| Poland | Ongoing, recruiting | 10 | 1 |
| Spain | Ongoing, recruiting | 24 | 6 |
| Rest of world
Moldova, Republic of, United States
|
— | 53 | — |
Investigational sites
Universitair Ziekenhuis Gent
Drug Research Unit Ghent, Corneel Heymanslaan 10, 9000, Gent
UZ Leuven
Digestive Oncology, Herestraat 49, 3000, Leuven
Grand Hopital De Charleroi
oncology Hematology, Rue Du Campus Des Viviers 1, 6060, Charleroi
Cliniques Universitaires Saint-Luc
medical oncology/ Institut Roi Albert II, Hippokrateslaan 10, Batiment 54, Sint-Lambrechts-Woluwe
Institut De Cancerologie De L Ouest
medical oncology, Boulevard Jacques Monod, 44805, Saint-Herblain Cedex
Institut De Cancerologie De L Ouest
medical oncology, 15 Rue Andre Boquel, 49100, Angers
Centre Leon Berard
medical oncology, 28 Rue Laennec, 69008, Lyon
Institut Gustave Roussy
DITEP, 114 Rue Edouard Vaillant, 94800, Villejuif
Institut Bergonie
medical oncology, 180 R De Saint Genes, 229 Cours De L Argonne, Bordeaux
Institut Paoli Calmettes
Medical Oncology, 232 Boulevard De Sainte Marguerite, Bp 156, Marseille
Hopital Europeen Georges Pompidou
Medical Oncology, 20 Rue Leblanc, 75015, Paris
Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie-Panstwowy Instytut Badawczy
Oddzial Badan Wczesnych Faz, Ul. Wilhelma Konrada Roentgena 5, 02-781, Warsaw
Hospital Universitario 12 De Octubre
oncology, Bloque D, Avenida De Cordoba S/n, Madrid
Hospital General Universitario Gregorio Maranon
oncology, Calle Del Doctor Esquerdo 46, 28009, Madrid
Fundacion Instituto Valenciano De Oncologia
oncology, Calle De Gregorio Gea 3 1 A Planta, 46009, Valencia
Institut Catala D'oncologia
oncology, Avinguda De La Gran Via De L'hospitalet 199-203, 08908, L'hospitalet De Llobregat
Hospital Universitari Vall D Hebron
oncology, Passeig De La Vall D'Hebron 119-129, 08035, Barcelona
Fundacion Rioja Salud
oncology, Calle Piqueras 98, 26006, Logrono
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 |
|---|---|---|---|---|---|
| Belgium | 2024-09-03 | 2024-09-30 | |||
| France | 2024-08-20 | 2024-11-26 | |||
| Poland | 2024-09-02 | 2024-09-13 | |||
| Spain | 2024-09-02 | 2024-09-19 |
Oversight and notifications
Regulatory notifications under CTR Articles 38, 52, 53, 54 and 77
Corrective measures 1 · Art. 77 CTR
Corrective measure CM-FR-0001
- Member state
- France
- Publication date
- 2023-10-18
- Type
- 3
- Reason
- 7
- Immediate action required
- Yes
- Justification
- In line with the version 6.4 of CTR Q&A / point 1.23, the sponsor is requested to submit a specific SM Part II only in France in order to update its CTA in line with the documentation approved during the appeal procedure within 10 days after the submission of this corrective measure.
Application history
10 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-04-11 | Spain | Acceptable 2023-07-24
|
2023-07-25 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2023-08-10 | Acceptable 2023-07-24
|
2023-08-10 | |
| 3 | SUBSTANTIAL MODIFICATION | SM-1 | 2023-10-26 | Acceptable | 2023-11-27 | |
| 4 | SUBSTANTIAL MODIFICATION | SM-2 | 2023-11-20 | Acceptable | 2023-12-21 | |
| 5 | SUBSTANTIAL MODIFICATION | SM-3 | 2024-05-09 | Spain | Acceptable 2024-07-19
|
2024-07-19 |
| 6 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2024-11-04 | Spain | Acceptable 2024-07-19
|
2024-11-04 |
| 7 | NON SUBSTANTIAL MODIFICATION | NSM-3 | 2025-05-29 | Spain | Acceptable 2024-07-19
|
2025-05-29 |
| 8 | SUBSTANTIAL MODIFICATION | SM-4 | 2025-10-23 | Spain | Acceptable 2026-02-16
|
2026-02-16 |
| 9 | SUBSTANTIAL MODIFICATION | SM-6 | 2026-04-21 | Spain | Acceptable | 2026-05-07 |
| 10 | SUBSTANTIAL MODIFICATION | SM-5 | 2026-04-30 | Acceptable | 2026-05-29 |