Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ongoing, recruitment ended
Participants planned
481
Countries
7
Sites
16
Advanced or metastatic solid tumors with KRAS G12C mutation
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 Jun 2021 → ongoing
- Decision date (initial)
- 2024-06-19
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2023-506311-18-00
- EudraCT number
- 2020-000084-22
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Advanced or metastatic solid tumors with KRAS G12C mutation
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | LLT | 10065252 | Solid tumor | 10029104 |
| 21.0 | LLT | 10049280 | Solid tumour | 10029104 |
| 21.1 | LLT | 10065143 | Malignant solid tumour | 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
7 EU/EEA countries · 16 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Belgium | Ongoing, recruitment ended | 24 | 3 |
| Hungary | Ended | 12 | 1 |
| Italy | Ongoing, recruitment ended | 26 | 1 |
| Netherlands | Ongoing, recruitment ended | 24 | 3 |
| Norway | Ongoing, recruitment ended | 12 | 2 |
| Poland | Ongoing, recruitment ended | 16 | 1 |
| Spain | Ongoing, recruitment ended | 42 | 5 |
| Rest of world
Brazil, United Kingdom, Australia, Israel, Kenya, Russian Federation, Korea, Republic of, Switzerland, United States, Canada, New Zealand
|
— | 325 | — |
Investigational sites
A.Z. Sint-Maarten
Oncology, Liersesteenweg 435, 2800, Mechelen
Centre hospitalier universitaire de Liege
Oncology, Avenue De L'hopital 1, 4000, Liege
Antwerp University Hospital
Oncology, Drie Eikenstraat 655, 2650, Edegem
Humanitas Mirasole S.p.A.
U.O. Oncologia Medica ed Ematologia, Via Alessandro Manzoni 56, 20089, Rozzano
Academisch Ziekenhuis Maastricht
Oncology, P Debyelaan 25, 6229 HX, Maastricht
Netherlands Cancer Institute
Oncology, Plesmanlaan 121, 1066 CX, Amsterdam
Universitair Medisch Centrum Utrecht
Oncology, Heidelberglaan 100, 3584 CX, Utrecht
Oslo University Hospital HF
The Department of Clinical Cancer Research, Taarnbygget, Kirkeveien 166, Oslo
Helse Bergen HF
Departement of thoracic medicine, Section of lung cancer and infection, Haukelandsveien 22, 5021, Bergen
Uniwersyteckie Centrum Kliniczne
Ośrodek Badań Klinicznych Wczesnych Faz, Ul. Mariana Smoluchowskiego 17, 80-214, Gdansk
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
Hospital Universitario 12 De Octubre
Oncology, Bloque D, Avenida De Cordoba Sn, Madrid
Hospital Universitario Virgen De La Victoria
Oncology, Calle Del Arroyo Teatinos Sn, 29010, Malaga
Hospital Universitari Vall D Hebron
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 | 2021-09-10 | 2021-09-24 | 2024-05-28 | ||
| Hungary | 2022-07-04 | 2024-08-18 | 2022-07-07 | 2023-06-09 | |
| Italy | 2021-11-23 | 2021-12-13 | 2024-05-28 | ||
| Netherlands | 2021-09-01 | 2021-09-03 | 2024-05-28 | ||
| Norway | 2022-05-12 | 2022-05-17 | 2024-05-28 | ||
| Poland | 2021-08-26 | 2021-09-23 | 2024-05-28 | ||
| Spain | 2021-06-29 | 2021-06-29 | 2024-05-28 |
Application history
8 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-05-07 | Netherlands | Acceptable with conditions 2024-06-19
|
2024-06-19 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2024-07-24 | Netherlands | Acceptable with conditions 2024-06-19
|
2024-07-24 |
| 3 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-09-04 | Netherlands | Acceptable 2024-12-06
|
2024-12-06 |
| 4 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-02-13 | Netherlands | Acceptable 2025-05-13
|
2025-05-13 |
| 5 | SUBSTANTIAL MODIFICATION | SM-3 | 2025-07-23 | Netherlands | Acceptable 2025-10-03
|
2025-10-03 |
| 6 | SUBSTANTIAL MODIFICATION | SM-4 | 2025-10-31 | Netherlands | Acceptable | 2025-12-02 |
| 7 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2025-12-15 | Netherlands | Acceptable | 2025-12-15 |
| 8 | NON SUBSTANTIAL MODIFICATION | NSM-3 | 2025-12-15 | Netherlands | Acceptable | 2025-12-15 |