Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ongoing, recruiting
Participants planned
92
Countries
3
Sites
6
Advanced solid tumors harboring KRAS G12C mutation
Key facts
- Sponsor
- Bayer AG
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 18 Nov 2024 → ongoing
- Decision date (initial)
- 2024-10-27
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Advanced solid tumors harboring KRAS G12C mutation
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | LLT | 10065147 | Malignant solid tumor | 10029104 |
| 25.1 | LLT | 10069759 | KRAS mutation | 10018065 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Bayer AG
- Sponsor organisation
- Bayer AG
- Address
- -
- City
- Leverkusen
- Postcode
- 51368
- Country
- Germany
Scientific contact point
- Organisation
- Bayer AG
- Contact name
- Therapeutic Area Head
Public contact point
- Organisation
- Bayer AG
- Contact name
- Therapeutic Area Head
Locations
3 EU/EEA countries · 6 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Denmark | Ongoing, recruiting | 19 | 1 |
| Italy | Ongoing, recruiting | 17 | 2 |
| Spain | Ongoing, recruiting | 17 | 3 |
| Rest of world
United Kingdom, Australia
|
— | 39 | — |
Investigational sites
Rigshospitalet
Department of oncology, Blegdamsvej 9, 2100, Copenhagen Oe
Humanitas Mirasole S.p.A.
Oncologia Medica ed Ematologia, Via Alessandro Manzoni 56, 20089, Rozzano
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Oncologia Medica, Largo Francesco Vito 1, 00168, Rome
Institut Catala D'oncologia
Medical Oncologist, Avinguda De La Gran Via De L'hospitalet 199-203, 08908, L'hospitalet De Llobregat
Hospital Universitari Vall D Hebron
Medical Oncologist, Passeig De La Vall D'Hebron 119-129, 08035, Barcelona
Institut Catala D'oncologia
Medical Oncologist, Avinguda De La Gran Via De L'hospitalet 199-203, 08908, L'hospitalet De Llobregat
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 |
|---|---|---|---|---|---|
| Denmark | 2024-12-03 | 2024-12-11 | |||
| Italy | 2024-11-18 | 2024-11-25 | |||
| Spain | 2025-02-11 | 2025-09-10 |
Application history
9 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-07-31 | Denmark | Acceptable 2024-10-15
|
2024-10-27 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-11-20 | Denmark | Acceptable 2025-02-11
|
2025-02-11 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-03-20 | Denmark | Acceptable 2025-05-02
|
2025-05-02 |
| 4 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-06-23 | Denmark | Acceptable 2025-05-02
|
2025-06-23 |
| 5 | SUBSTANTIAL MODIFICATION | SM-3 | 2025-07-01 | Denmark | Acceptable 2025-09-05
|
2025-09-05 |
| 6 | SUBSTANTIAL MODIFICATION | SM-4 | 2025-09-26 | Denmark | Acceptable | 2025-10-01 |
| 7 | SUBSTANTIAL MODIFICATION | SM-5 | 2025-12-09 | Denmark | Acceptable 2026-02-05
|
2026-02-05 |
| 8 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2026-02-19 | Denmark | Acceptable 2026-02-05
|
2026-02-19 |
| 9 | SUBSTANTIAL MODIFICATION | SM-6 | 2026-04-14 | Acceptable | 2026-05-04 |