Overview
Sponsor-declared trial summary
Phase
Phase I and Phase II (Integrated) - First administration to humans
Status
Ongoing, recruiting
Participants planned
208
Countries
1
Sites
3
Cancer – Solid Tumors : 1L NSCLC and all other advanced or metastatic solid tumors with KRAS alterations (KRAS mutation or KRAS amplification)
Key facts
- Sponsor
- Merck Sharp & Dohme LLC
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 14 Jan 2026 → ongoing
- Decision date (initial)
- 2025-12-23
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2025-522495-84-00
- WHO UTN
- U1111-1323-3663
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Cancer – Solid Tumors : 1L NSCLC and all other advanced or metastatic solid tumors with KRAS alterations (KRAS mutation or KRAS amplification)
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | LLT | 10065252 | Solid tumor | 10029104 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Merck Sharp & Dohme LLC
- Sponsor organisation
- Merck Sharp & Dohme LLC
- Address
- 126 East Lincoln Avenue, P. O. Box 2000 P. O. Box 2000
- City
- Rahway
- Postcode
- 07065-4607
- Country
- United States
Scientific contact point
- Organisation
- Merck Sharp & Dohme LLC
- Contact name
- Marie Will
Public contact point
- Organisation
- Merck Sharp & Dohme LLC
- Contact name
- Marie Will
Locations
1 EU/EEA country · 3 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Spain | Ongoing, recruiting | 29 | 3 |
| Rest of world
Korea, Republic of, Chile, Israel, Canada, United States, Australia
|
— | 179 | — |
Investigational sites
Hospital Clinic De Barcelona
Medical Oncology, Calle Villarroel 170, 08036, Barcelona
Hospital Universitario Fundacion Jimenez Diaz
Medical Oncology, Avenida De Los Reyes Catolicos 2, 28040, Madrid
Hospital Universitari Vall D Hebron
Medical 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 |
|---|---|---|---|---|---|
| Spain | 2026-01-14 | 2026-01-30 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-09-26 | Spain | Acceptable 2025-12-18
|
2025-12-23 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2026-03-18 | Spain | Acceptable 2026-05-04
|
2026-05-05 |