Overview
Sponsor-declared trial summary
Patients with pretreated, metastatic or locally advanced cancer for the dose escalation part and dose expansion cohorts in patients with advanced triple-negative breast cancers and advanced cancers with ATM mutation.
Key facts
- Sponsor
- Institut Curie
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 20 Jan 2025 → 24 Nov 2025
- Decision date (initial)
- 2024-03-11
- 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
Patients with pretreated, metastatic or locally advanced cancer for the dose escalation part and dose expansion cohorts in patients with advanced triple-negative breast cancers and advanced cancers with ATM mutation.
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 23.0 | LLT | 10084066 | Triple negative breast cancer metastatic | 10029104 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Institut Curie
- Sponsor organisation
- Institut Curie
- Address
- 26 Rue D Ulm
- City
- Paris
- Postcode
- 75005
- Country
- France
Scientific contact point
- Organisation
- Institut Curie
- Contact name
- Luc CABEL
Public contact point
- Organisation
- Institut Curie
- Contact name
- AZZOUZ
Locations
1 EU/EEA country · 2 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Ended | 92 | 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 |
|---|---|---|---|---|---|
| France | 2025-01-20 | 2025-01-20 | 2025-09-30 |
Application history
3 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-11-09 | France | Acceptable 2024-03-11
|
2024-03-11 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-05-27 | France | Acceptable 2025-06-20
|
2025-07-03 |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-12-17 | France | Acceptable 2025-06-20
|
2025-12-17 |