Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ongoing, recruitment ended
Participants planned
400
Countries
5
Sites
21
Advanced Breast Cancer and Other Solid Tumors
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
- 27 Jul 2023 → ongoing
- Decision date (initial)
- 2024-07-08
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2023-509568-81-00
- EudraCT number
- 2022-000175-40
- WHO UTN
- U1111-1299-5539
- ClinicalTrials.gov
- NCT05307705
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Advanced Breast Cancer and Other Solid Tumors
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
- Medical Monitor
Public contact point
- Organisation
- Eli Lilly & Co.
- Contact name
- Medical Monitor
Locations
5 EU/EEA countries · 21 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Belgium | Ended | 15 | 2 |
| France | Ongoing, recruitment ended | 32 | 7 |
| Germany | Ended | 10 | 3 |
| Italy | Ended | 10 | 1 |
| Spain | Ended | 33 | 8 |
| Rest of world
Canada, Australia, China, United States, Japan, Korea, Republic of, United Kingdom, Singapore
|
— | 300 | — |
Investigational sites
Institut Jules Bordet
Oncology, Mijlenmeersstraat 90, 1070, Anderlecht
UZ Leuven
Gynecological Oncology, Breast Center, Herestraat 49, 3000, Leuven
Institut Gustave Roussy
medical oncology, 114 Rue Edouard Vaillant, 94800, Villejuif
Institut Curie
medical oncology, 26 Rue D Ulm, 75005, Paris
Centre Leon Berard
medical oncology, 28 Rue Laennec, 69008, Lyon
Centre Francois Baclesse
breast pathology, 3 Avenue Du General Harris, Cs 45026, Caen Cedex 5
Institut Curie
medical oncology, 35 Rue Dailly, 92210, Saint-Cloud
Institut De Cancerologie Strasbourg Europe
medical oncology, 17 Rue Albert Calmette, 67200, Strasbourg
Institut De Cancerologie De L Ouest
medical oncology, Boulevard Jacques Monod, 44805, Saint-Herblain Cedex
Universitaetsklinikum Erlangen AöR
Department of Gynecology and Obstetrics, Frauenklinik, Universitätsklinikum Erlangen, Universitaetsstrasse 21-23, Innenstadt, Erlangen
Goethe University Frankfurt
Med. Klinik II, Universitätsklinikum Frankfurt, Theodor-Stern-Kai 7, 60590, Frankfurt Am Main
Universitaetsklinikum Tuebingen AöR
Medizinische Klinik-Innere Medizin VIII, Universitätsklinikum Tübingen, Otfried-Mueller-Strasse 10, Nordstadt, Tuebingen
Istituto Europeo Di Oncologia S.r.l.
Divisione di Sviluppo di Nuovi Farmaci per Terapie Innovative, Via Giuseppe Ripamonti 435, 20141, Milan
Hospital Arnau De Vilanova De Valencia
Oncology, Calle De San Clemente 12, 46015, Valencia
Hospital Universitari Dexeus Grupo Quironsalud
Oncology, Calle De Sabino Arana 5-19, 08028, Barcelona
Hospital Universitario Quironsalud Madrid
Oncology, Calle De Diego De Velazquez 1, 28223, Pozuelo De Alarcon
Hospital Clinico Universitario De Valencia
Oncology, Avenida Blasco Ibanez 17, 46010, Valencia
Hospital Universitari Vall D Hebron
Oncology, Passeig De La Vall D'Hebron 119-129, 08035, Barcelona
Hospital General Universitario Gregorio Maranon
Oncology, Calle Del Doctor Esquerdo 46, 28009, Madrid
Hospital Universitario 12 De Octubre
Oncology, Bloque D, Avenida De Cordoba Sn, Madrid
Hospital Clinic De Barcelona
Oncology, Calle Villarroel 170, 08036, 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 |
|---|---|---|---|---|---|
| Belgium | 2023-08-09 | 2025-06-16 | 2023-10-26 | 2024-07-19 | |
| France | 2023-07-27 | 2023-09-07 | 2024-07-19 | ||
| Germany | 2023-08-15 | 2024-07-19 | 2023-12-12 | 2024-07-19 | |
| Italy | 2024-02-13 | 2024-07-19 | 2024-03-25 | 2024-07-19 | |
| Spain | 2023-07-27 | 2026-04-23 | 2023-08-11 | 2024-07-19 |
Application history
9 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-05-31 | France | Acceptable 2024-07-05
|
2024-07-08 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-09-26 | France | Acceptable 2025-01-17
|
2025-01-17 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-04-10 | France | Acceptable 2025-05-23
|
2025-05-23 |
| 4 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-06-30 | France | Acceptable 2025-05-23
|
2025-06-30 |
| 5 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2025-06-30 | Acceptable 2025-05-23
|
2025-06-30 | |
| 6 | NON SUBSTANTIAL MODIFICATION | NSM-3 | 2025-07-01 | Acceptable 2025-05-23
|
2025-07-01 | |
| 7 | SUBSTANTIAL MODIFICATION | SM-5 | 2025-08-27 | France | Acceptable | 2025-10-03 |
| 8 | NON SUBSTANTIAL MODIFICATION | NSM-4 | 2025-10-03 | 2025-10-03 | ||
| 9 | SUBSTANTIAL MODIFICATION | SM-6 | 2025-11-24 | France | Acceptable | 2025-12-17 |