Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Authorised, recruitment pending
Participants planned
201
Countries
1
Sites
1
Ovarian Neoplasms Breast Neoplasms Pancreatic Intraductal Neoplasms Colorectal Neoplasms Esophageal Neoplasms Stomach Neoplasms Cholangiocarcinoma
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)
- 2026-07-07
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2025-521887-37-00
- WHO UTN
- U1111-1332-3899
- ClinicalTrials.gov
- NCT07213791
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Ovarian Neoplasms Breast Neoplasms Pancreatic Intraductal Neoplasms Colorectal Neoplasms Esophageal Neoplasms Stomach Neoplasms Cholangiocarcinoma
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 | 24 | 1 |
| Rest of world
Japan, United States
|
— | 177 | — |
Investigational sites
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2026-03-17 | Acceptable with conditions 2026-07-06
|
2026-07-07 |