Overview
Sponsor-declared trial summary
Dose Escalation: Non-small cell lung cancer (NSCLC), colorectal cancer (CRC), gastric cancer (GC), melanoma (MEL). Dose Confirmation: Lead Indication based on data from dose escalation. Dose Expansion: Tertiary Lymphoid Structure positive (TLS+) CRC, GC, and NSCLC.
Key facts
- Sponsor
- Amgen Inc.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 13 Jun 2024 → ongoing
- Decision date (initial)
- 2024-05-22
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2023-509047-26-00
- WHO UTN
- U1111-1301-0488
- ClinicalTrials.gov
- NCT06131398
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Dose Escalation: Non-small cell lung cancer (NSCLC), colorectal cancer (CRC), gastric cancer (GC), melanoma (MEL). Dose Confirmation: Lead Indication based on data from dose escalation. Dose Expansion: Tertiary Lymphoid Structure positive (TLS+) CRC, GC, and NSCLC.
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | LLT | 10065147 | Malignant solid tumor | 10029104 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Amgen Inc.
- Sponsor organisation
- Amgen Inc.
- Address
- 1 Amgen Center Drive
- City
- Thousand Oaks
- Postcode
- 91320-1799
- Country
- United States
Scientific contact point
- Organisation
- Amgen Inc.
- Contact name
- Medical Information
Public contact point
- Organisation
- Amgen Inc.
- Contact name
- Medical Information
Locations
4 EU/EEA countries · 8 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Ongoing, recruitment ended | 35 | 2 |
| Netherlands | Ended | 40 | 2 |
| Poland | Ongoing, recruitment ended | 25 | 1 |
| Spain | Ended | 35 | 3 |
| Rest of world
Korea, Republic of, United States, Australia, Canada, Switzerland, Taiwan, Japan
|
— | 400 | — |
Investigational sites
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 |
|---|---|---|---|---|---|
| France | 2024-07-23 | 2024-11-19 | 2025-11-03 | ||
| Netherlands | 2024-07-15 | 2024-10-02 | 2025-11-03 | ||
| Poland | 2024-06-13 | 2024-07-05 | 2025-11-03 | ||
| Spain | 2024-07-03 | 2024-08-19 | 2025-11-03 |
Application history
5 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-01-31 | Spain | Acceptable 2024-05-16
|
2024-05-16 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-05-30 | Acceptable | 2024-06-07 | |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2024-10-28 | Acceptable | 2025-01-22 | |
| 4 | SUBSTANTIAL MODIFICATION | SM-3 | 2025-02-21 | Spain | Acceptable 2025-06-02
|
2025-06-03 |
| 5 | SUBSTANTIAL MODIFICATION | SM-4 | 2025-11-04 | Spain | Acceptable 2026-03-02
|
2026-03-02 |