Overview
Sponsor-declared trial summary
Advanced cancer histologies for which immune checkpoint blockade is an approved treatment option, such as: Metastatic melanoma, Lung cancer, Renal Cell Carcinoma (RCC), Hodgkin’s lymphoma, Microsatellite Instability (MSI)-high colon cancer, Hepatocellular Carcinoma (HCC), and Gastric cancer.
Key facts
- Sponsor
- MabQuest Therapeutics S.A.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Pathological Conditions, Signs and Symptoms [C23]
- Trial duration
- 29 May 2024 → ongoing
- Decision date (initial)
- 2024-02-19
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2023-507774-41-00
- ClinicalTrials.gov
- NCT06514651
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Advanced cancer histologies for which immune checkpoint blockade is an approved treatment option, such as: Metastatic melanoma, Lung cancer, Renal Cell Carcinoma (RCC), Hodgkin’s lymphoma, Microsatellite Instability (MSI)-high colon cancer, Hepatocellular Carcinoma (HCC), and Gastric cancer.
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
MabQuest Therapeutics S.A.
- Sponsor organisation
- MabQuest Therapeutics S.A.
- Address
- Avenue D'Ouchy 4
- City
- Lausanne
- Postcode
- 1006
- Country
- Switzerland
Scientific contact point
- Organisation
- MabQuest S.A.
- Contact name
- Clinical trial information
Public contact point
- Organisation
- MabQuest S.A.
- Contact name
- Clinical trial information
Locations
1 EU/EEA country · 4 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Ongoing, recruiting | 30 | 4 |
| 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 |
|---|---|---|---|---|---|
| France | 2024-05-29 | 2024-07-01 |
Application history
8 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-10-30 | France | Acceptable 2024-02-12
|
2024-02-19 |
| 2 | SUBSTANTIAL MODIFICATION | SM-2 | 2024-02-21 | France | Acceptable 2024-05-14
|
2024-05-14 |
| 3 | SUBSTANTIAL MODIFICATION | SM-3 | 2024-05-16 | France | Acceptable | 2024-06-05 |
| 4 | SUBSTANTIAL MODIFICATION | SM-4 | 2024-10-14 | France | Acceptable 2025-01-20
|
2025-01-20 |
| 5 | SUBSTANTIAL MODIFICATION | SM-5 | 2025-06-06 | France | Acceptable 2025-06-20
|
2025-06-23 |
| 6 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-07-03 | France | Acceptable 2025-06-20
|
2025-07-03 |
| 7 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2025-10-16 | France | Acceptable 2025-06-20
|
2025-10-16 |
| 8 | SUBSTANTIAL MODIFICATION | SM-6 | 2026-02-02 | France | Acceptable 2026-02-27
|
2026-03-18 |