Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ongoing, recruiting
Participants planned
88
Countries
5
Sites
17
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
- 16 Aug 2023 → ongoing
- Decision date (initial)
- 2024-01-15
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2023-504709-35-00
- EudraCT number
- 2021-006708-34
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 |
|---|---|---|---|---|
| 21.0 | LLT | 10049280 | Solid tumour | 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
5 EU/EEA countries · 17 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Belgium | Ongoing, recruiting | 6 | 3 |
| Greece | Ongoing, recruiting | 12 | 3 |
| Netherlands | Ongoing, recruiting | 4 | 2 |
| Spain | Ongoing, recruiting | 12 | 7 |
| Sweden | Ongoing, recruiting | 10 | 2 |
| Rest of world
United States, Korea, Republic of, Australia, Canada
|
— | 44 | — |
Investigational sites
CHU De Liege
n/a, Avenue De L'hopital 1, 4000, Liege
Antwerp University Hospital
Oncology, Drie Eikenstraat 655, 2650, Edegem
Ziekenhuis Aan De Stroom
Oncology, Oosterveldlaan 24, 2610, Antwerp
University General Hospital Attikon
2nd Propaedeutic Pathology Clinic, Rimini Street 1, 124 62, Athens
Thoracic General Hospital Of Athens I Sotiria
Oncology Unit, 3'd Department of Ιnternal Medicine and Laboratory, Messogion Avenue 152, 115 27, Athens
General Hospital Of Thessaloniki Papageorgiou
Molecular Medicine Clinic, Ring Road Of Thessaloniki, Ministry Of Pavlos Melas, Efkarpia
Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis Stichting
Medical Oncology, Plesmanlaan 121, 1066 CX, Amsterdam
Universitair Medisch Centrum Groningen
Medical Oncology, Hanzeplein 1, 9713 GZ, Groningen
Hospital Universitario Virgen De La Victoria
Medical Oncology, Calle Del Arroyo Teatinos Sn, 29010, Malaga
Hospital Clinico Universitario De Valencia
Oncology, Avenida Blasco Ibanez 17, 46010, Valencia
Hospital Universitario Quironsalud Madrid
Oncology, Calle De Diego De Velazquez 1, 28223, Pozuelo De Alarcon
Hospital Universitario Fundacion Jimenez Diaz
Oncology, Avenida De Los Reyes Catolicos 2, 28040, Madrid
Hospital Universitari Vall D Hebron
Medical Oncology, Edificio Materno-Infantil, Passeig De La Vall D'hebron 119-129, Barcelona
Hospital Universitario 12 De Octubre
ORG-100028548, Bloque D, Avenida De Cordoba Sn, Madrid
Institut Catala D'oncologia
Medical Oncology, Avinguda De La Gran Via De L'hospitalet 199-203, 08908, L'hospitalet De Llobregat
Karolinska University Hospital
Centrum för Kliniska Cancerstudier, Fas 1-enheten, Eugeniavagen 3, 17164, Solna
Sahlgrenska University Hospital-Vastra Gotalandsregionen
Avdelningen för Onkologi Jubileumsklinken, Bruna Stråket 5, 413 46, Gothenburg
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 | 2023-11-28 | 2023-11-28 | |||
| Greece | 2025-05-30 | 2025-09-11 | |||
| Netherlands | 2024-02-08 | 2024-02-08 | |||
| Spain | 2023-08-16 | 2023-08-16 | |||
| Sweden | 2025-06-24 | 2025-11-14 |
Application history
11 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-11-23 | Belgium | Acceptable 2024-01-15
|
2024-01-15 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-06-17 | Belgium | Acceptable with conditions 2024-09-16
|
2024-09-16 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2024-12-03 | Belgium | Acceptable 2025-03-11
|
2025-03-11 |
| 4 | SUBSEQUENT ADDITION OF MSC | APP-4 | 2025-03-26 | Acceptable 2025-03-11
|
2025-05-16 | |
| 5 | SUBSEQUENT ADDITION OF MSC | APP-5 | 2025-03-26 | Acceptable 2025-03-11
|
2025-06-02 | |
| 6 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-03-26 | Belgium | Acceptable 2025-03-11
|
2025-03-26 |
| 7 | SUBSTANTIAL MODIFICATION | SM-3 | 2025-07-04 | Belgium | Acceptable 2025-08-26
|
2025-08-26 |
| 8 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2025-10-10 | Acceptable 2025-08-26
|
2025-10-10 | |
| 9 | NON SUBSTANTIAL MODIFICATION | NSM-3 | 2025-10-23 | Acceptable 2025-08-26
|
2025-10-23 | |
| 10 | SUBSTANTIAL MODIFICATION | SM-6 | 2025-10-24 | Acceptable | 2025-12-03 | |
| 11 | SUBSTANTIAL MODIFICATION | SM-7 | 2026-03-13 | Belgium | Acceptable | 2026-04-03 |