Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ended
Participants planned
275
Countries
4
Sites
12
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
- 21 Apr 2021 → 28 May 2026
- Decision date (initial)
- 2024-04-22
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2023-506285-31-00
- EudraCT number
- 2019-003986-16
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 |
|---|---|---|---|---|
| 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
4 EU/EEA countries · 12 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Belgium | Ended | 7 | 1 |
| Italy | Ended | 19 | 3 |
| Netherlands | Ended | 35 | 3 |
| Spain | Ended | 38 | 5 |
| Rest of world
Korea, Republic of, United States, Canada, Australia, Brazil
|
— | 176 | — |
Investigational sites
Istituto Europeo Di Oncologia S.r.l.
Divisione di Sviluppo di Nuovi Farmaci per Terapie Innovative, Via Giuseppe Ripamonti 435, 20141, Milan
Humanitas Research Hospital
Unità Operativa di Oncologia ed Ematologia, Via Alessandro Manzoni 56, 20089, Rozzano
Fondazione IRCCS Istituto Nazionale Dei Tumori
SC Oncologia Medica I, Via Giacomo Venezian 1, 20133, Milan
Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis Stichting
Medical Oncology, Plesmanlaan 121, 1066 CX, Amsterdam
Amsterdam UMC Stichting
Medical Oncology, De Boelelaan 1117, 1081 HV, Amsterdam
Universitair Medisch Centrum Groningen
Medical Oncology, Hanzeplein 1, 9713 GZ, Groningen
Clinica Universidad De Navarra
Servicio de Oncologia, Avenue Pio XII 36, 31008, Pamplona
Clinica Universidad De Navarra
Servicio de Oncologia, Calle Marquesado De Santa Marta 1, 28027, Madrid
Hospital Clinico Universitario De Valencia
Servicio de Oncologia, Avenida Blasco Ibanez 17, 46010, Valencia
Hospital Universitario Fundacion Jimenez Diaz
Servicio de Oncologia, Avenida De Los Reyes Catolicos 2, 28040, Madrid
Hospital General Universitario Reina Sofia
Servicio de Oncologia, Avenida Menendez Pidal S/n, 14004, Cordoba
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 |
|---|---|---|---|---|---|
| Belgium | 2023-12-11 | 2024-06-20 | 2024-01-16 | 2024-04-11 | |
| Italy | 2023-10-13 | 2026-04-30 | 2023-12-18 | 2024-08-20 | |
| Netherlands | 2021-04-21 | 2026-05-27 | 2021-06-09 | 2024-08-21 | |
| Spain | 2023-11-22 | 2026-05-22 | 2023-12-18 | 2024-06-03 |
Application history
7 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-03-19 | Netherlands | Acceptable 2024-04-15
|
2024-04-15 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-07-11 | Netherlands | Acceptable 2024-09-16
|
2024-09-17 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2024-11-28 | Netherlands | Acceptable 2025-02-17
|
2025-02-18 |
| 4 | SUBSTANTIAL MODIFICATION | SM-3 | 2025-05-19 | Netherlands | Acceptable 2025-08-25
|
2025-08-25 |
| 5 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2026-01-15 | Netherlands | Acceptable 2025-08-25
|
2026-01-15 |
| 6 | SUBSTANTIAL MODIFICATION | SM-4 | 2026-02-02 | Netherlands | Acceptable 2026-04-24
|
2026-04-24 |
| 7 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2026-05-26 | Netherlands | Acceptable 2026-04-24
|
2026-05-26 |