Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ongoing, recruiting
Participants planned
321
Countries
2
Sites
4
Cancer
Key facts
- Sponsor
- Eli Lilly & Co.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 24 Oct 2025 → ongoing
- Decision date (initial)
- 2025-09-29
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2025-521916-20-00
- WHO UTN
- U1111-1322-0061
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Cancer
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | LLT | 10065252 | Solid tumor | 10029104 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Eli Lilly & Co.
- Sponsor organisation
- Eli Lilly & Co.
- Address
- 1 Lilly Corporate Center
- City
- Indianapolis
- Postcode
- 46285-0001
- Country
- United States
Scientific contact point
- Organisation
- Eli Lilly & Co.
- Contact name
- Eli Lilly & Co.
Public contact point
- Organisation
- Eli Lilly & Co.
- Contact name
- Eli Lilly & Co.
Locations
2 EU/EEA countries · 4 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Ongoing, recruiting | 40 | 2 |
| Spain | Ongoing, recruiting | 40 | 2 |
| Rest of world
Korea, Republic of, Japan, United States
|
— | 241 | — |
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 | 2025-11-21 | 2025-11-27 | |||
| Spain | 2025-10-24 | 2025-11-11 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-06-13 | Spain | Acceptable 2025-09-26
|
2025-09-29 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-10-07 | Spain | Acceptable 2025-09-26
|
2025-10-07 |