Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Authorised, recruitment pending
Participants planned
36
Countries
1
Sites
1
Advanced breast cancer and advanced NSCLC
Key facts
- Sponsor
- Novartis Pharma AG
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Decision date (initial)
- 2025-07-03
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Advanced breast cancer and advanced NSCLC
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | PT | 10006187 | Breast cancer | 100000004864 |
| 20.0 | PT | 10058467 | Lung neoplasm malignant | 100000004864 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Novartis Pharma AG
- Sponsor organisation
- Novartis Pharma AG
- Address
- Lichtstrasse 35
- City
- Basel
- Postcode
- 4056
- Country
- Switzerland
Scientific contact point
- Organisation
- Novartis Pharma AG
- Contact name
- Novartis Pharma Arzneimittel GmbH
Public contact point
- Organisation
- Novartis Pharma AG
- Contact name
- Novartis Pharma Arzneimittel GmbH
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Netherlands | Authorised, recruitment pending | 36 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Pharmaceutical Research Associates Group B.V.
Program Management, Van Swietenlaan 6, 9728 NZ, Groningen
Application history
5 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-04-28 | Netherlands | Acceptable 2025-07-03
|
2025-07-03 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2026-01-30 | Netherlands | Acceptable | 2026-02-13 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2026-04-15 | Netherlands | Acceptable 2026-04-21
|
2026-04-21 |
| 4 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2026-05-06 | Netherlands | Acceptable 2026-04-21
|
2026-05-06 |
| 5 | SUBSTANTIAL MODIFICATION | SM-3 | 2026-05-13 | Netherlands | Acceptable | 2026-05-21 |