Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ended
Participants planned
197
Countries
1
Sites
2
Advanced or metastatic breast cancer and other advanced or metastatic solid tumors
Key facts
- Sponsor
- Genentech Inc.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 10 May 2024 → 16 Feb 2026
- Decision date (initial)
- 2024-05-10
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2023-508124-36-00
- EudraCT number
- 2016-003022-17
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Advanced or metastatic breast cancer and other advanced or metastatic solid tumors
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 23.0 | PT | 10081234 | PIK3CA-activated mutation | 100000004850 |
| 20.0 | PT | 10006187 | Breast cancer | 100000004864 |
| 20.0 | LLT | 10027475 | Metastatic breast cancer | 10029104 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Genentech Inc.
- Sponsor organisation
- Genentech Inc.
- Address
- 1 Dna Way
- City
- South San Francisco
- Postcode
- 94080-4918
- Country
- United States
Scientific contact point
- Organisation
- Genentech Inc.
- Contact name
- US Program Manager Product Development Regulatory
Public contact point
- Organisation
- Genentech Inc.
- Contact name
- US Program Manager Product Development Regulatory
Locations
1 EU/EEA country · 2 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Spain | Ended | 41 | 2 |
| Rest of world
United States, Canada, United Kingdom
|
— | 156 | — |
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 |
|---|---|---|---|---|---|
| Spain | 2024-05-10 | 2026-02-16 | 2024-05-10 |
Application history
10 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-04-17 | Spain | Acceptable 2024-05-10
|
2024-05-10 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-06-14 | Spain | Acceptable 2024-07-30
|
2024-07-30 |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2024-08-28 | Spain | Acceptable 2024-07-30
|
2024-08-28 |
| 4 | SUBSTANTIAL MODIFICATION | SM-2 | 2024-10-04 | Spain | Acceptable 2024-11-12
|
2024-11-12 |
| 5 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2024-12-09 | Spain | Acceptable 2024-11-12
|
2024-12-09 |
| 6 | SUBSTANTIAL MODIFICATION | SM-3 | 2024-12-13 | Spain | Acceptable 2025-02-11
|
2025-02-11 |
| 7 | SUBSTANTIAL MODIFICATION | SM-4 | 2025-03-18 | Spain | Acceptable 2025-04-10
|
2025-05-27 |
| 8 | SUBSTANTIAL MODIFICATION | SM-5 | 2025-10-27 | Spain | Acceptable 2025-12-11
|
2025-12-15 |
| 9 | NON SUBSTANTIAL MODIFICATION | NSM-3 | 2025-12-19 | Spain | Acceptable 2025-12-11
|
2025-12-19 |
| 10 | NON SUBSTANTIAL MODIFICATION | NSM-4 | 2026-02-16 | Spain | Acceptable 2025-12-11
|
2026-02-16 |