Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ongoing, recruiting
Participants planned
539
Countries
3
Sites
8
Ovarian cancer, endometrial cancer, cervical cancer, non-small cell lung cancer, triple-negative breast cancer, pancreatic cancer and colorectal 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
- 20 Sep 2024 → ongoing
- Decision date (initial)
- 2024-08-09
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2024-511238-11-00
- WHO UTN
- U1111-1304-8794
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Ovarian cancer, endometrial cancer, cervical cancer, non-small cell lung cancer, triple-negative breast cancer, pancreatic cancer and colorectal 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
3 EU/EEA countries · 8 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Ongoing, recruiting | 96 | 3 |
| Italy | Ongoing, recruiting | 35 | 2 |
| Spain | Ongoing, recruiting | 92 | 3 |
| Rest of world
Japan, Australia, Korea, Republic of, United States
|
— | 316 | — |
Investigational sites
Centre Leon Berard
Medical Oncology, 28 Rue Laennec, 69008, Lyon
Institut De Cancerologie De L Ouest
Medical Oncology, Boulevard Jacques Monod, 44805, Saint-Herblain Cedex
Institut Universitaire Du Cancer Toulouse-Oncopole
Medical Oncology, 1 Avenue Irene Joliot Curie, 31059, Toulouse Cedex 9
Istituto Europeo Di Oncologia S.r.l.
Divisione di Sviluppo di Nuovi Farmaci per Terapie Innovative, Via Giuseppe Ripamonti 435, 20141, Milan
Humanitas Mirasole S.p.A.
Gynecologic Oncology Unit, Via Francesco Nava 31, 20159, Milan
Hospital Clinico Universitario De Valencia
Medical Oncology, Avenida Blasco Ibanez 17, 46010, Valencia
Hospital Universitario 12 De Octubre
Medical Oncology, Bloque D, Avenida De Cordoba Sn, Madrid
Hospital Universitari Vall D Hebron
Medical Oncology, Passeig De La Vall D'Hebron 119-129, 08035, Barcelona
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 | 2024-09-25 | 2024-10-01 | |||
| Italy | 2024-12-03 | 2025-01-17 | |||
| Spain | 2024-09-20 | 2024-09-25 |
Application history
14 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-04-22 | France | Acceptable 2024-08-09
|
2024-08-09 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2024-08-28 | Acceptable 2024-08-09
|
2024-08-28 | |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2024-10-21 | Acceptable 2024-08-09
|
2024-10-21 | |
| 4 | NON SUBSTANTIAL MODIFICATION | NSM-3 | 2024-10-29 | France | Acceptable 2024-08-09
|
2024-10-29 |
| 5 | NON SUBSTANTIAL MODIFICATION | NSM-4 | 2024-11-15 | France | Acceptable 2024-08-09
|
2024-11-15 |
| 6 | NON SUBSTANTIAL MODIFICATION | NSM-5 | 2024-11-19 | Acceptable 2024-08-09
|
2024-11-19 | |
| 7 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-04-10 | France | Acceptable 2025-06-26
|
2025-06-26 |
| 8 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-10-14 | France | Acceptable 2025-12-23
|
2026-01-09 |
| 9 | NON SUBSTANTIAL MODIFICATION | NSM-6 | 2026-01-15 | Acceptable 2025-12-23
|
2026-01-15 | |
| 10 | SUBSTANTIAL MODIFICATION | SM-3 | 2026-02-02 | Acceptable | 2026-03-18 | |
| 11 | SUBSTANTIAL MODIFICATION | SM-4 | 2026-02-02 | Acceptable | 2026-02-13 | |
| 12 | NON SUBSTANTIAL MODIFICATION | NSM-7 | 2026-03-20 | France | Acceptable | 2026-03-20 |
| 13 | NON SUBSTANTIAL MODIFICATION | NSM-8 | 2026-03-20 | France | Acceptable | 2026-03-20 |
| 14 | SUBSTANTIAL MODIFICATION | SM-5 | 2026-04-30 | France | Acceptable 2026-06-02
|
2026-06-02 |