Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Authorised, recruitment pending
Participants planned
134
Countries
2
Sites
7
Locally 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]
- Decision date (initial)
- 2025-02-24
- 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
Locally Advanced or Metastatic Solid Tumors
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | PT | 10033128 | Ovarian cancer | 100000004864 |
| 27.0 | PT | 10057529 | Ovarian cancer metastatic | 100000004864 |
| 21.0 | PT | 10073251 | Clear cell renal cell carcinoma | 100000004864 |
| 20.1 | LLT | 10080007 | Clear cell renal cell carcinoma metastatic | 10029104 |
| 21.1 | LLT | 10065252 | Solid tumor | 10029104 |
| 21.1 | LLT | 10065147 | Malignant solid tumor | 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
2 EU/EEA countries · 7 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Czechia | Authorised, recruitment pending | 8 | 2 |
| Spain | Authorised, recruitment pending | 15 | 5 |
| Rest of world
Singapore, United States, United Kingdom, Australia, Korea, Republic of, Canada
|
— | 111 | — |
Investigational sites
University Hospital Olomouc
n/a, Zdravotniku 248/7, 779 00, Olomouc
Masarykuv Onkologicky Ustav
n/a, Zluty Kopec 543/7, Stare Brno, Brno-Stred
Clinica Universidad De Navarra
Servicio de oncologia, Pio XII Etorbidea 36, 31008, Pamplona
Hospital Universitario Fundacion Jimenez Diaz
Servicio de oncologia, Avenida De Los Reyes Catolicos 2, 28040, Madrid
Hospital Clinico Universitario De Valencia
Servicio de oncologia, Avenida Blasco Ibanez 17, 46010, Valencia
Hospital Universitari Vall D Hebron
Servicio de oncologia, Passeig De La Vall D'Hebron 119-129, 08035, Barcelona
Clinica Universidad De Navarra
Servicio de oncologia, Calle Marquesado De Santa Marta 1, 28027, Madrid
Application history
3 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-10-22 | Spain | Acceptable with conditions 2025-02-18
|
2025-02-18 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-10-02 | Spain | Acceptable 2025-11-18
|
2025-11-19 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2026-02-03 | Spain | Acceptable 2026-03-23
|
2026-03-25 |