Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ongoing, recruitment ended
Participants planned
466
Countries
3
Sites
10
Advanced/metastatic solid tumor
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
- 14 Oct 2024 → ongoing
- Decision date (initial)
- 2024-05-23
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2023-509867-26-00
- WHO UTN
- U1111-1300-2546
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Advanced/metastatic solid tumor
| 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
3 EU/EEA countries · 10 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Belgium | Ongoing, recruitment ended | 23 | 1 |
| France | Ongoing, recruitment ended | 50 | 5 |
| Spain | Ongoing, recruitment ended | 53 | 4 |
| Rest of world
Japan, China, Australia, United States
|
— | 340 | — |
Investigational sites
Institut Jules Bordet
001:Oncologie Médicale, Mijlenmeersstraat 90, 1070, Anderlecht
Institut Gustave Roussy
104: Département d'innovation Thérapeutique et Essais Précoces (DITEP), 114 Rue Edouard Vaillant, 94800, Villejuif
Centre Leon Berard
101: département d'oncologie médica, 28 Rue Laennec, 69008, Lyon
Les Hopitaux Universitaires De Strasbourg
106: Medical Oncology, 1 Avenue Moliere, Bp 49, Strasbourg Cedex 2
Centre Oscar Lambret
105: Cancérologie Générale, 3 Rue Frederic Combemale, 59000, Lille
Institut Paoli-Calmettes
102: Oncologie Medicale - Cancerolo, 232 Boulevard De Sainte Marguerite, Bp 156, Marseille
MD Anderson Cancer Center
201: Oncología, Calle De Arturo Soria Nº 270, 28033, Madrid
Hospital Universitari Vall D Hebron
204:Oncología Médica, Passeig De La Vall D'Hebron 119-129, 08035, Barcelona
Hospital Universitario 12 De Octubre
202:Oncología Médica, Bloque D, Avenida De Cordoba Sn, Madrid
University Hospital Virgen Del Rocio S.L.
203:Oncología, Avenida De Manuel Siurot S/n, 41013, Sevilla
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 |
|---|---|---|---|---|---|
| Belgium | 2024-10-25 | 2024-10-29 | 2026-03-03 | ||
| France | 2024-12-16 | 2024-12-27 | 2026-03-03 | ||
| Spain | 2024-10-14 | 2024-10-29 | 2026-03-03 |
Application history
7 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-01-31 | France | Acceptable with conditions 2024-05-21
|
2024-05-22 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-06-11 | France | Acceptable 2024-08-29
|
2024-08-30 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-01-13 | France | Acceptable 2025-03-25
|
2025-03-25 |
| 4 | SUBSTANTIAL MODIFICATION | SM-3 | 2025-04-01 | Acceptable | 2025-04-09 | |
| 5 | SUBSTANTIAL MODIFICATION | SM-4 | 2025-06-24 | France | Acceptable 2025-08-29
|
2025-08-29 |
| 6 | SUBSTANTIAL MODIFICATION | SM-5 | 2025-10-10 | Acceptable | 2025-10-23 | |
| 7 | SUBSTANTIAL MODIFICATION | SM-6 | 2025-10-24 | France | Acceptable | 2025-11-13 |