Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Authorised, recruitment pending
Participants planned
421
Countries
1
Sites
1
Breast Neoplasms Colorectal Neoplasms Prostate Neoplasm Endometrial Neoplasms Neoplasm Metastasis
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]
- Decision date (initial)
- 2026-03-05
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2025-522367-15-00
- WHO UTN
- U1111-1328-0821
- ClinicalTrials.gov
- NCT07114601
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Breast Neoplasms Colorectal Neoplasms Prostate Neoplasm Endometrial Neoplasms Neoplasm Metastasis
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
- Lilly Clinical Trials information desk
Public contact point
- Organisation
- Eli Lilly & Co.
- Contact name
- Lilly Clinical Trials information desk
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Germany | Authorised, recruitment pending | 53 | 1 |
| Rest of world
Canada, United States
|
— | 368 | — |
Investigational sites
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-12-29 | Germany | Acceptable 2026-03-04
|
2026-03-05 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2026-03-13 | Germany | Acceptable 2026-03-31
|
2026-04-01 |