Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ongoing, recruitment ended
Participants planned
363
Countries
6
Sites
16
Human epidermal growth factor receptor (HER2)-Expressing Cancers
Key facts
- Sponsor
- Genentech Inc.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Health Care [N] - Environment and Public Health [N06], Diseases [C] - Neoplasms [C04]
- Trial duration
- 30 Oct 2020 → ongoing
- Decision date (initial)
- 2023-10-12
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2023-504491-15-00
- EudraCT number
- 2019-004596-39
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Human epidermal growth factor receptor (HER2)-Expressing Cancers
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | PT | 10006187 | Breast cancer | 100000004864 |
| 21.1 | PT | 10017758 | Gastric cancer | 100000004864 |
| 21.1 | LLT | 10065252 | 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
- 94080-4990
- 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
6 EU/EEA countries · 16 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Belgium | Ended | 10 | 1 |
| Denmark | Ended | 20 | 1 |
| France | Ongoing, recruitment ended | 40 | 4 |
| Italy | Ongoing, recruitment ended | 30 | 3 |
| Netherlands | Ended | 20 | 2 |
| Spain | Ended | 67 | 5 |
| Rest of world
United Kingdom, Singapore, Japan, United States, Australia, Korea, Republic of, Taiwan, Canada
|
— | 176 | — |
Investigational sites
Rigshospitalet
Department of Oncology, Blegdamsvej 9, 2100, Copenhagen Oe
Institut Bergonie
Early Phase Trials and Sarcoma Units, 229 Cours De L Argonne, 33000, Bordeaux
Centre Leon Berard
Médecine, 28 Rue Laennec, 69008, Lyon
Institut Gustave Roussy
Early Drug Development Department, 114 Rue Edouard Vaillant, 94800, Villejuif
Institut Universitaire Du Cancer Toulouse-Oncopole
Medical Oncology, 1 Avenue Irene Joliot Curie, 31059, Toulouse Cedex 9
ASST Grande Ospedale Metropolitano Niguarda
Dipartimento di Onco-ematologia, SC Oncologia, Piazza Dell'ospedale Maggiore 3, 20162, Milan
Humanitas Research Hospital
Unità Operativa di Oncologia ed Ematologia, Via Alessandro Manzoni 56, 20089, Rozzano
European Institute Of Oncology S.r.l.
Divisione di Sviluppo di Nuovi Farmaci per Terapie Innovative, Via Giuseppe Ripamonti 435, 20141, Milan
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
Medical Oncology, Dr. Molewaterplein 40, 3015 GD, Rotterdam
Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis Stichting
Medical Oncology, Plesmanlaan 121, 1066 CX, Amsterdam
Hospital Universitario Quironsalud Madrid
Oncology, Calle De Diego De Velazquez 1, 28223, Pozuelo De Alarcon
Hospital Universitario Hm Sanchinarro
Oncology, Calle Ona 10, 28050, Madrid
Hospital Clinico Universitario De Valencia
Oncology, Avenida Blasco Ibanez 17, 46010, Valencia
Hospital Universitario Fundacion Jimenez Diaz
Oncology, Avenida De Los Reyes Catolicos 2, 28040, Madrid
Vall D'hebron Institut De Recerca
Oncology, Passeig De La Vall D'hebron 119-129, 08035, Barcelona
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 | 2021-09-23 | 2024-05-29 | 2023-04-03 | 2024-02-19 | |
| Denmark | 2021-09-21 | 2024-06-07 | 2022-03-10 | 2024-02-19 | |
| France | 2021-07-07 | 2021-10-18 | 2024-02-19 | ||
| Italy | 2021-09-27 | 2021-10-27 | 2024-02-19 | ||
| Netherlands | 2021-10-14 | 2024-02-19 | 2022-04-28 | 2024-02-19 | |
| Spain | 2020-10-30 | 2024-09-02 | 2021-04-26 | 2024-02-19 |
Application history
9 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-09-08 | Spain | Acceptable 2023-10-10
|
2023-10-10 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2023-12-15 | Spain | Acceptable 2024-03-13
|
2024-03-13 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2024-08-23 | Spain | Acceptable 2024-10-01
|
2024-10-01 |
| 4 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2024-12-16 | Spain | Acceptable 2024-10-01
|
2024-12-16 |
| 5 | SUBSTANTIAL MODIFICATION | SM-5 | 2025-01-28 | Acceptable 2025-03-11
|
2025-03-12 | |
| 6 | SUBSTANTIAL MODIFICATION | SM-6 | 2025-07-08 | Acceptable 2025-10-02
|
2025-10-02 | |
| 7 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2025-11-26 | Spain | Acceptable 2025-10-02
|
2025-11-26 |
| 8 | NON SUBSTANTIAL MODIFICATION | NSM-3 | 2025-12-12 | Spain | Acceptable 2025-10-02
|
2025-12-12 |
| 9 | SUBSTANTIAL MODIFICATION | SM-7 | 2026-02-05 | Acceptable | 2026-03-05 |