Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ongoing, recruitment ended
Participants planned
139
Countries
1
Sites
2
Advanced Hematologic Malignancies
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
- 4 Feb 2021 → ongoing
- Decision date (initial)
- 2024-10-29
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2024-515149-41-00
- EudraCT number
- 2020-002830-33
- ClinicalTrials.gov
- NCT04603001
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Advanced Hematologic Malignancies
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | LLT | 10065252 | Solid tumor | 10029104 |
| 21.1 | LLT | 10066481 | Hematological malignancy | 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
1 EU/EEA country · 2 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Ongoing, recruitment ended | 34 | 2 |
| Rest of world
Canada, Korea, Republic of, United States
|
— | 105 | — |
Investigational sites
Hopital Saint Louis
Centre d´Investigation Cliniques, 1 Avenue Claude Vellefaux, 75010, Paris
Hospices Civils De Lyon
Hématologie, 165 Chemin Du Grand Revoyet, 69310, Pierre Benite
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 | 2021-02-04 | 2021-02-08 | 2023-02-24 |
Application history
4 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-09-04 | France | Acceptable 2024-10-29
|
2024-10-29 |
| 2 | SUBSTANTIAL MODIFICATION | SM-2 | 2024-12-20 | France | Acceptable 2025-01-08
|
2025-01-08 |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-04-11 | France | Acceptable 2025-01-08
|
2025-04-11 |
| 4 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2026-02-04 | France | Acceptable 2025-01-08
|
2026-02-04 |