Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ended
Participants planned
160
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]
- Trial duration
- 29 Nov 2023 → 16 Mar 2026
- Decision date (initial)
- 2023-11-14
- 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
Locally Advanced or Metastatic Solid Tumors
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | LLT | 10025648 | Malignant mast cell tumors unspecified site extranodal and solid organ sites | 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
- 94080-4990
- 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 |
|---|---|---|---|
| Italy | Ended | 17 | 3 |
| Spain | Ended | 18 | 4 |
| Rest of world
New Zealand, Serbia, Brazil, Korea, Republic of, Japan, Australia, United States, Turkey
|
— | 125 | — |
Investigational sites
Centro Ricerche Cliniche Di Verona S.r.l.
Oncology, Piazzale Ludovico Antonio Scuro 10, 37134, Verona
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Oncology, Largo Francesco Vito 1, 00168, Rome
ASST Grande Ospedale Metropolitano Niguarda
Oncology, Piazza Dell'ospedale Maggiore 3, 20162, Milan
Clinica Universidad De Navarra
Servicio Oncología, Avenue Pio XII 36, 31008, Pamplona
Hospital Universitario Quironsalud Madrid
Servicio Oncología, Calle De Diego De Velazquez 1, 28223, Pozuelo De Alarcon
Clinica Universidad De Navarra
Servicio Oncología, Calle Marquesado De Santa Marta 1, 28027, Madrid
Hospital Clinico Universitario De Valencia
Servicio Oncología, Avenida Blasco Ibanez 17, 46010, Valencia
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 |
|---|---|---|---|---|---|
| Italy | 2023-12-11 | 2025-04-23 | 2024-01-16 | 2024-11-20 | |
| Spain | 2023-11-29 | 2026-01-22 | 2023-12-05 | 2024-11-20 |
Application history
5 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-07-21 | Spain | Acceptable 2023-11-10
|
2023-11-10 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-04-17 | Spain | Acceptable 2024-06-27
|
2024-06-27 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2024-10-01 | Spain | Acceptable 2024-11-06
|
2024-11-15 |
| 4 | SUBSTANTIAL MODIFICATION | SM-3 | 2025-07-15 | Spain | Acceptable 2025-09-08
|
2025-09-10 |
| 5 | SUBSTANTIAL MODIFICATION | SM-5 | 2025-11-18 | Spain | Acceptable 2026-01-19
|
2026-01-21 |