Overview
Sponsor-declared trial summary
Dose escalation cohort: advanced and/or metastatic cancer car-cinoma of the breast, stomach, esophagus, pancreas, endometri-um, ovary or lung. Expansion cohort: HER2-expressing, i.e HER2-positive and HER2-low breast cancer
Key facts
- Sponsor
- Institut Paoli-Calmettes
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 21 Jan 2022 → ongoing
- Decision date (initial)
- 2023-11-23
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2023-504605-36-00
- EudraCT number
- 2021-002692-19
- WHO UTN
- U1111-1291-5585
- ClinicalTrials.gov
- NCT05143970
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Dose escalation cohort: advanced and/or metastatic cancer car-cinoma of the breast, stomach, esophagus, pancreas, endometri-um, ovary or lung. Expansion cohort: HER2-expressing, i.e HER2-positive and HER2-low breast cancer
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Institut Paoli-Calmettes
- Sponsor organisation
- Institut Paoli-Calmettes
- Address
- 232 Boulevard De Sainte Marguerite, Bp 156 Bp 156
- City
- Marseille
- Postcode
- 13009
- Country
- France
Scientific contact point
- Organisation
- Institut Paoli-Calmettes
- Contact name
- GONCALVES
Public contact point
- Organisation
- Institut Paoli-Calmettes
- Contact name
- LAROSA
Locations
2 EU/EEA countries · 3 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Belgium | Ongoing, recruitment ended | 4 | 1 |
| France | Ongoing, recruitment ended | 21 | 2 |
| 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 |
|---|---|---|---|---|---|
| Belgium | 2024-04-24 | 2024-04-24 | 2026-03-21 | ||
| France | 2022-01-21 | 2022-01-21 | 2026-03-21 |
Application history
4 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-05-17 | France | Acceptable 2023-07-28
|
2023-08-02 |
| 2 | SUBSEQUENT ADDITION OF MSC | APP-2 | 2023-09-13 | Acceptable 2023-07-28
|
2023-11-23 | |
| 3 | SUBSTANTIAL MODIFICATION | SM-4 | 2024-03-08 | France | Acceptable 2024-05-06
|
2024-05-14 |
| 4 | SUBSTANTIAL MODIFICATION | SM-6 | 2025-04-10 | France | Acceptable 2025-06-04
|
2025-06-04 |