Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ended
Participants planned
228
Countries
2
Sites
4
Advanced tumors
Key facts
- Sponsor
- Genentech Inc.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Not possible to specify, Diseases [C] - Neoplasms [C04]
- Trial duration
- 3 Jul 2018 → 1 Jul 2025
- Decision date (initial)
- 2024-08-28
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2023-504224-26-00
- EudraCT number
- 2017-001475-23
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Advanced tumors
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 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
- 94080-4990
- 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 · 4 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Belgium | Ended | 19 | 1 |
| Germany | Ended | 22 | 3 |
| Rest of world
United Kingdom, United States
|
— | 187 | — |
Investigational sites
Universitaetsklinikum Heidelberg AöR
National Center for Tumor Diseases (NCT), Im Neuenheimer Feld 460, Neuenheim, Heidelberg
Universitaetsklinikum Heidelberg AöR
Department of Clinical Pharmacology and Pharmacoepidemiology, Im Neuenheimer Feld 410, Neuenheim, Heidelberg
Universitaetsklinikum Essen AöR
Westdeutsches Tumorzentrum - Innere Klinik (Tumorforschung), Hufelandstrasse 55, Holsterhausen, Essen
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 | 2018-07-03 | 2025-06-25 | 2018-10-08 | 2020-11-17 | |
| Germany | 2018-08-31 | 2025-06-16 | 2019-02-15 | 2021-08-04 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-08-12 | Germany | Acceptable with conditions 2024-08-28
|
2024-08-28 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-12-19 | Germany | Acceptable 2025-03-24
|
2025-03-25 |