Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ongoing, recruiting
Participants planned
535
Countries
6
Sites
16
Locally Advanced or Metastatic Solid Tumors with FGFR3 Alterations
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
- 30 Aug 2023 → ongoing
- Decision date (initial)
- 2023-06-28
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2022-502755-59-00
- WHO UTN
- U1111-1286-3894
- ClinicalTrials.gov
- NCT05614739
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Locally Advanced or Metastatic Solid Tumors with FGFR3 Alterations
| 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
- Patient Advocacy
Public contact point
- Organisation
- Eli Lilly & Co.
- Contact name
- Patient Advocacy
Locations
6 EU/EEA countries · 16 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Ongoing, recruiting | 27 | 4 |
| Germany | Ongoing, recruiting | 7 | 2 |
| Italy | Ongoing, recruiting | 8 | 2 |
| Netherlands | Ongoing, recruiting | 6 | 1 |
| Norway | Ongoing, recruiting | 7 | 2 |
| Spain | Ongoing, recruiting | 30 | 5 |
| Rest of world
Australia, Israel, China, Japan, Canada, United States, Korea, Republic of, United Kingdom
|
— | 450 | — |
Investigational sites
Institut Gustave Roussy
Early drug development, 114 Rue Edouard Vaillant, 94800, Villejuif
Institut Bergonie
Medical Oncology, 229 Cours De L Argonne, 33000, Bordeaux
Centre Leon Berard
Medical Oncology, 28 Rue Laennec, 69008, Lyon
Institut Claudius Regaud
Medical Oncology, 1 Avenue Irene Joliot Curie, 31100, Toulouse
Universitaetsklinikum Tuebingen
Internal Medicine, Otfried-Mueller-Strasse 10, Nordstadt, Tuebingen
Klinikum rechts der Isar der TU Muenchen AöR
Urology, Ismaninger Strasse 22, Au-Haidhausen, Munich
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
UOC Fase 1, Largo Francesco Vito 1, 00168, Rome
Ospedale San Raffaele S.r.l.
Unità di Oncologia Medica, Via Olgettina 60, 20132, Milan
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
Medical Oncology, Dr. Molewaterplein 40, 3015 GD, Rotterdam
Helse Bergen HF
Haukeland University Hospital - Bergen, Jonas Lies Vei 65, 5021, Bergen
Oslo University Hospital HF
Department of oncology, Taarnbygget, Kirkeveien 166, Oslo
Hospital Universitario Hm Sanchinarro
Oncology, Calle Ona 10, 28050, Madrid
Hospital Universitario Marques De Valdecilla
Oncology, 5 Planta, Avenida Valdecilla S/n, Santander
Hospital Universitario 12 De Octubre
Oncology, Bloque D, Avenida De Cordoba S/n, Madrid
Catalan Institute Of Oncology
Oncology, Avinguda Gran Via De L'hospitalet 199-203, 08908, L'hospitalet De Llobregat
MD Anderson Cancer Center
Oncology, Calle De Arturo Soria Nº 270, 28033, Madrid
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 | 2023-10-05 | 2024-06-26 | |||
| Germany | 2023-08-30 | 2024-05-06 | |||
| Italy | 2024-05-22 | 2024-07-24 | |||
| Netherlands | 2024-03-18 | 2024-07-04 | |||
| Norway | 2023-12-19 | 2024-03-12 | |||
| Spain | 2023-10-30 | 2024-02-21 |
Application history
14 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-03-03 | Norway | Acceptable 2023-06-26
|
2023-06-28 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2023-07-07 | Norway | Acceptable 2023-06-26
|
2023-07-07 |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2023-07-07 | Acceptable 2023-06-26
|
2023-07-07 | |
| 4 | NON SUBSTANTIAL MODIFICATION | NSM-3 | 2023-07-10 | Acceptable 2023-06-26
|
2023-07-10 | |
| 5 | NON SUBSTANTIAL MODIFICATION | NSM-4 | 2023-07-10 | Acceptable 2023-06-26
|
2023-07-10 | |
| 6 | NON SUBSTANTIAL MODIFICATION | NSM-5 | 2023-07-11 | Acceptable 2023-06-26
|
2023-07-11 | |
| 7 | NON SUBSTANTIAL MODIFICATION | NSM-6 | 2023-07-21 | Acceptable 2023-06-26
|
2023-07-21 | |
| 8 | NON SUBSTANTIAL MODIFICATION | NSM-7 | 2023-08-10 | Acceptable 2023-06-26
|
2023-08-10 | |
| 9 | SUBSTANTIAL MODIFICATION | SM-1 | 2023-10-20 | Norway | Acceptable 2024-01-30
|
2024-01-30 |
| 10 | SUBSTANTIAL MODIFICATION | SM-2 | 2024-04-19 | Norway | Acceptable 2024-06-24
|
2024-06-25 |
| 11 | SUBSTANTIAL MODIFICATION | SM-3 | 2024-07-09 | Norway | Acceptable 2024-08-26
|
2024-08-26 |
| 12 | SUBSTANTIAL MODIFICATION | SM-4 | 2025-04-25 | Norway | Acceptable 2025-07-30
|
2025-07-30 |
| 13 | SUBSTANTIAL MODIFICATION | SM-5 | 2025-09-24 | Norway | Acceptable 2025-11-10
|
2025-11-12 |
| 14 | SUBSTANTIAL MODIFICATION | SM-6 | 2026-02-09 | Norway | Acceptable 2026-04-14
|
2026-04-14 |