Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ongoing, recruiting
Participants planned
30
Countries
1
Sites
3
Advanced and/or metastatic solid tumours (colorectal cancer, ovarian cancer, pancreatic cancer or renal cell carcinoma)
Key facts
- Sponsor
- Molecure S.A.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 23 Aug 2023 → ongoing
- Decision date (initial)
- 2024-05-06
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2024-513006-61-00
- EudraCT number
- 2022-003806-61
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Advanced and/or metastatic solid tumours (colorectal cancer, ovarian cancer, pancreatic cancer or renal cell carcinoma)
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.0 | PT | 10061451 | Colorectal cancer | 100000004864 |
| 20.0 | PT | 10033128 | Ovarian cancer | 100000004864 |
| 21.1 | PT | 10067946 | Renal cell carcinoma | 100000004864 |
| 21.1 | LLT | 10065252 | Solid tumor | 10029104 |
| 21.0 | LLT | 10033604 | Pancreatic cancer | 10029104 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Molecure S.A.
- Sponsor organisation
- Molecure S.A.
- Address
- Ul. Zwirki I Wigury 101
- City
- Warsaw
- Postcode
- 02-089
- Country
- Poland
Scientific contact point
- Organisation
- Molecure S.A.
- Contact name
- Clinical development
Public contact point
- Organisation
- Molecure S.A.
- Contact name
- contact
Locations
1 EU/EEA country · 3 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Poland | Ongoing, recruiting | 30 | 3 |
| Rest of world | — | 0 | — |
Investigational sites
Centrum Onkologii Im. Prof. Franciszka Lukaszczyka W Bydgoszczy
Ambulatorium Chemioterapii, Ul. Izabeli Romanowskiej 2, 85-796, Bydgoszcz
Europejskie Centrum Zdrowia Otwock Sp. z o.o.
Klinika Onkologii, Ul. Borowa 14/18, 05-400, Otwock
Lux Med Onkologia Sp. z o.o.
Oddział Onkologii Klinicznej/Chemioterapii, Ul. Szamocka 6, 01-748, Warsaw
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 |
|---|---|---|---|---|---|
| Poland | 2023-08-23 | 2023-08-23 |
Application history
4 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-04-10 | Poland | Acceptable 2024-04-29
|
2024-05-06 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2024-08-01 | Poland | Acceptable 2024-04-29
|
2024-08-01 |
| 3 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-08-08 | Poland | Acceptable 2025-09-19
|
2025-09-23 |
| 4 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2026-02-19 | Poland | Acceptable 2025-09-19
|
2026-02-19 |