Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ended
Participants planned
194
Countries
1
Sites
3
Advanced or Metastatic Solid Tumors with KRAS Mutations or Amplifications
Key facts
- Sponsor
- BeOne Medicines AG
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- completed 23 Apr 2026
- Decision date (initial)
- 2025-04-11
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2024-514704-13-00
- ClinicalTrials.gov
- NCT06585488
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Advanced or Metastatic Solid Tumors with KRAS Mutations or Amplifications
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | LLT | 10079440 | Non-squamous non-small cell lung cancer | 10029104 |
| 27.0 | LLT | 10058546 | Esophageal adenocarcinoma metastatic | 10029104 |
| 21.1 | LLT | 10051971 | Pancreatic adenocarcinoma | 10029104 |
| 27.0 | LLT | 10084871 | Gastroesophageal junction cancer metastatic | 100000004848 |
| 21.0 | PT | 10061451 | Colorectal cancer | 100000004864 |
| 27.0 | PT | 10063916 | Metastatic gastric cancer | 100000004864 |
| 27.0 | PT | 10052358 | Colorectal cancer metastatic | 100000004864 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
BeOne Medicines AG
- Sponsor organisation
- BeOne Medicines AG
- Address
- Aeschengraben 27
- City
- Basel
- Postcode
- 4051
- Country
- Switzerland
Scientific contact point
- Organisation
- BeOne Medicines AG
- Contact name
- BeOne Medical Officer
Public contact point
- Organisation
- BeOne Medicines AG
- Contact name
- BeOne Medical Officer
Locations
1 EU/EEA country · 3 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Spain | Ended | 30 | 3 |
| Rest of world
China, Korea, Republic of, New Zealand, Australia, United States
|
— | 164 | — |
Investigational sites
Application history
5 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-01-21 | Spain | Acceptable 2025-03-17
|
2025-04-11 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-05-19 | Spain | Acceptable 2025-07-07
|
2025-07-08 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-07-30 | Spain | Acceptable 2025-09-12
|
2025-09-15 |
| 4 | SUBSTANTIAL MODIFICATION | SM-3 | 2025-10-01 | Spain | Acceptable 2025-10-02
|
2025-10-02 |
| 5 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2026-04-30 | Spain | Acceptable 2025-10-02
|
2026-04-30 |