Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ongoing, recruiting
Participants planned
132
Countries
2
Sites
7
Advanced or Metastatic Prostate Cancer
Key facts
- Sponsor
- Genentech Inc.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 6 Sep 2024 → ongoing
- Decision date (initial)
- 2023-11-27
- 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
Advanced or Metastatic Prostate Cancer
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | PT | 10036909 | Prostate cancer metastatic | 100000004864 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Genentech Inc.
- Sponsor organisation
- Genentech Inc.
- Address
- 1 Dna Way
- City
- South San Francisco
- Postcode
- 94080-4990
- 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
2 EU/EEA countries · 7 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Ongoing, recruiting | 6 | 3 |
| Spain | Ongoing, recruiting | 16 | 4 |
| Rest of world
United States, Canada, Korea, Republic of, Australia, United Kingdom, Singapore
|
— | 110 | — |
Investigational sites
Institut Gustave Roussy
Service d’Oncologie Médicale, 114 Rue Edouard Vaillant, 94800, Villejuif
Centre Leon Berard
Service d’Oncologie Médicale, 28 Rue Laennec, 69008, Lyon
Institut Paoli-Calmettes
Unité de Soins Ambulatoires, 232 Boulevard De Sainte Marguerite, Bp 156, Marseille
Hospital Universitari Vall D Hebron
Servicio de oncologia medica, Passeig De La Vall D'Hebron 119-129, 08035, Barcelona
Hospital Clinico San Carlos
Servicio de oncologia medica, Calle Del Profesor Martin Lagos Sn, 28040, Madrid
Clinica Universidad De Navarra
Servicio de oncologia medica, Calle Marquesado De Santa Marta 1, 28027, Madrid
Clinica Universidad De Navarra
Servicio de oncologia medica, Avenue Pio XII 36, 31008, Pamplona
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 | 2024-10-04 | 2024-10-16 | |||
| Spain | 2024-09-06 | 2024-09-18 |
Application history
8 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-08-01 | Spain | Acceptable 2023-11-20
|
2023-11-22 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-05-18 | Spain | Acceptable 2024-07-17
|
2024-07-17 |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2024-08-30 | Acceptable 2024-07-17
|
2024-08-30 | |
| 4 | SUBSTANTIAL MODIFICATION | SM-3 | 2024-12-19 | Spain | Acceptable with conditions 2025-03-19
|
2025-03-19 |
| 5 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2025-04-10 | Acceptable with conditions 2025-03-19
|
2025-04-10 | |
| 6 | SUBSTANTIAL MODIFICATION | SM-4 | 2025-06-24 | Spain | Acceptable 2025-09-11
|
2025-09-12 |
| 7 | SUBSTANTIAL MODIFICATION | SM-5 | 2025-10-22 | Spain | Acceptable 2026-02-06
|
2026-02-06 |
| 8 | NON SUBSTANTIAL MODIFICATION | NSM-3 | 2026-02-26 | Spain | Acceptable 2026-02-06
|
2026-02-26 |