Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Authorised, recruiting
Participants planned
103
Countries
3
Sites
8
Advanced solid tumors
Key facts
- Sponsor
- MonTa Biosciences ApS
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 10 Apr 2024 → ongoing
- Decision date (initial)
- 2024-04-22
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2024-512294-26-00
- EudraCT number
- 2020-004858-30
- ClinicalTrials.gov
- NCT04855435
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Advanced solid tumors
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | LLT | 10065252 | Solid tumor | 10029104 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
MonTa Biosciences ApS
- Sponsor organisation
- MonTa Biosciences ApS
- Address
- Diplomvej 381
- City
- Kongens Lyngby
- Postcode
- 2800
- Country
- Denmark
Scientific contact point
- Organisation
- MonTa Biosciences ApS
- Contact name
- Morten Petersen
Public contact point
- Organisation
- MonTa Biosciences ApS
- Contact name
- Simon Jensen
Locations
3 EU/EEA countries · 8 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Belgium | Ended | 20 | 1 |
| Denmark | Ongoing, recruiting | 40 | 2 |
| Spain | Ongoing, recruiting | 43 | 5 |
| Rest of world | — | 0 | — |
Investigational sites
Institut Jules Bordet
Oncology, Mijlenmeersstraat 90, 1070, Anderlecht
Region Hovedstaden
Oncology, Borgmester Ib Juuls Vej 1, 2730, Herlev
Rigshospitalet
Oncology, Blegdamsvej 9, 2100, Copenhagen Oe
Institut Catala D'oncologia
Oncology, Avinguda De La Gran Via De L'hospitalet 199-203, 08908, L'hospitalet De Llobregat
Consorcio Hospital General Universitario De Valencia
Oncology, Avenida Tres Cruces 2, 46014, Valencia
Hospital Universitario Fundacion Jimenez Diaz
Oncology, Avenida De Los Reyes Catolicos 2, 28040, Madrid
Hospital Hm Nou Delfos
Oncology, Avinguda De Vallcarca 151, 08023, Barcelona
Hospital Universitario Hm Sanchinarro
Oncology, Calle Ona 10, 28050, Madrid
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 |
|---|---|---|---|---|---|
| Denmark | 2024-04-10 | 2024-04-10 | |||
| Spain | 2024-04-12 | 2024-04-23 |
Application history
6 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-03-08 | Denmark | Acceptable 2024-04-08
|
2024-04-09 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-05-27 | Denmark | Acceptable 2024-08-15
|
2024-08-15 |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2024-10-11 | Denmark | Acceptable 2024-08-15
|
2024-10-11 |
| 4 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2025-03-17 | Denmark | Acceptable 2024-08-15
|
2025-03-17 |
| 5 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-12-02 | Denmark | Acceptable 2026-02-12
|
2026-02-13 |
| 6 | SUBSTANTIAL MODIFICATION | SM-3 | 2026-04-17 | Denmark | Acceptable 2026-05-29
|
2026-05-29 |