Overview
Sponsor-declared trial summary
Multiple solid tumors including: colorectal carcinoma (CRC), pancreatic carcinoma, oesophageal or gastric carcinoma, head and neck squamous cell carcinoma (HNSCC), chondrosarcoma or osteosarcoma, bladder carcinoma, lung carcinoma and glioblastoma.
Key facts
- Sponsor
- Var2 Pharmaceuticals ApS
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 29 Nov 2024 → ongoing
- Decision date (initial)
- 2024-09-24
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Multiple solid tumors including: colorectal carcinoma (CRC), pancreatic carcinoma, oesophageal or gastric carcinoma, head and neck squamous cell carcinoma (HNSCC), chondrosarcoma or osteosarcoma, bladder carcinoma, lung carcinoma and glioblastoma.
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | LLT | 10065147 | Malignant solid tumor | 10029104 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Var2 Pharmaceuticals ApS
- Sponsor organisation
- Var2 Pharmaceuticals ApS
- Address
- Ole Maaloees Vej 3
- City
- Copenhagen N
- Postcode
- 2200
- Country
- Denmark
Scientific contact point
- Organisation
- Var2 Pharmaceuticals ApS
- Contact name
- Ali Salanti
Public contact point
- Organisation
- Var2 Pharmaceuticals ApS
- Contact name
- Ali Salanti
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Netherlands | Ongoing, recruiting | 32 | 1 |
| Rest of world | — | 0 | — |
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 |
|---|---|---|---|---|---|
| Netherlands | 2024-11-29 | 2024-12-10 |
Application history
4 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-08-12 | Netherlands | Acceptable 2024-09-24
|
2024-09-24 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-02-25 | Netherlands | Acceptable 2025-03-06
|
2025-03-07 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-05-06 | Netherlands | Acceptable 2025-05-15
|
2025-05-15 |
| 4 | SUBSTANTIAL MODIFICATION | SM-3 | 2025-10-30 | Netherlands | Acceptable 2025-11-27
|
2025-12-01 |