Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ongoing, recruiting
Participants planned
358
Countries
4
Sites
20
Advanced Solid Tumors, Advanced Breast Cancer
Key facts
- Sponsor
- Onkure Inc.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 9 Aug 2024 → ongoing
- Decision date (initial)
- 2024-04-18
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2023-508435-31-00
- WHO UTN
- U1111-1301-7789
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Advanced Solid Tumors, Advanced Breast Cancer
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | LLT | 10072737 | Advanced breast cancer | 10029104 |
| 21.1 | LLT | 10065252 | Solid tumor | 10029104 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Onkure Inc.
- Sponsor organisation
- Onkure Inc.
- Address
- 6707 Winchester Circle Suite 400
- City
- Boulder
- Postcode
- 80301-3534
- Country
- United States
Scientific contact point
- Organisation
- Onkure Inc.
- Contact name
- Ann Howell
Public contact point
- Organisation
- Onkure Inc.
- Contact name
- Ann Howell
Locations
4 EU/EEA countries · 20 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Belgium | Ongoing, recruiting | 18 | 4 |
| France | Ongoing, recruiting | 70 | 6 |
| Italy | Ongoing, recruiting | 20 | 3 |
| Spain | Ongoing, recruiting | 37 | 7 |
| Rest of world
United States, Korea, Republic of
|
— | 213 | — |
Investigational sites
Institut Jules Bordet
MEDICAL ONCOLOGY/ HEAD OF CTCU, Mijlenmeersstraat 90, 1070, Anderlecht
Ziekenhuis Aan De Stroom
Oncology, Oosterveldlaan 24, 2610, Antwerp
UZ Leuven
Oncology, Herestraat 49, 3000, Leuven
Antwerp University Hospital
Oncology, Drie Eikenstraat 655, 2650, Edegem
Centr Georges Francois Leclerc
Early Phase unit_Medical Oncology Department, 1 Rue Professeur Marion, 21000, Dijon
Centre Antoine Lacassagne
Medical Oncology Department, 33 Avenue De Valombrose, 06189, Nice Cedex 2
Centre Leon Berard
Medical Oncology Department, 28 Rue Laennec, 69008, Lyon
Hospices Civils De Lyon
Medical Oncology, 165 Chemin Du Grand Revoyet, 69310, Pierre Benite
Institut Gustave Roussy
Medicine, 114 Rue Edouard Vaillant, 94800, Villejuif
Centre Oscar Lambret
Medical Oncology Department, 3 Rue Frederic Combemale, 59000, Lille
Fondazione IRCCS San Gerardo Dei Tintori
Phase I Research Center, Via Giovanni Battista Pergolesi 33, 20900, Monza
Humanitas Research Hospital
Phase I Unit, Via Alessandro Manzoni 56, 20089, Rozzano
Ospedale San Raffaele S.r.l.
UO Oncologia Medica, Via Olgettina 60, 20132, Milan
Hospital Hm Nou Delfos
Medical Oncology, Avinguda De Vallcarca 151, 08023, Barcelona
Hospital Universitario Hm Sanchinarro
Phase I Trials Unit, Calle Ona 10, 28050, Madrid
Hospital Quironsalud Barcelona
Next Oncology. IOB, Placa D'alfonso Comin 5-7, 08023, Barcelona
Hospital Universitario Quironsalud Madrid
Medical Oncology, Calle De Diego De Velazquez 1, 28223, Pozuelo De Alarcon
Hospital Beata Maria Ana
IOB Madrid Institute of Oncology, Calle Del Doctor Esquerdo No. 83, 28007, Madrid
Hospital Universitario 12 De Octubre
Medical Oncology, Bloque D, Avenida De Cordoba Sn, Madrid
Hospital Universitari Arnau De Vilanova De La Gerencia Territorial De Lleida
Medical Oncology, Avinguda De L'alcalde Rovira Roure 80, 25196, Lleida
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 | 2025-01-14 | 2025-01-14 | |||
| France | 2024-11-12 | 2024-11-12 | |||
| Italy | 2024-11-21 | 2024-11-21 | |||
| Spain | 2024-08-09 | 2024-08-09 |
Application history
13 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-01-18 | Belgium | Acceptable with conditions 2024-04-18
|
2024-04-18 |
| 2 | SUBSTANTIAL MODIFICATION | SM-4 | 2024-05-06 | Belgium | Acceptable 2024-07-02
|
2024-07-02 |
| 3 | SUBSTANTIAL MODIFICATION | SM-5 | 2024-07-12 | Acceptable | 2024-08-12 | |
| 4 | SUBSTANTIAL MODIFICATION | SM-6 | 2024-07-12 | Acceptable | 2024-08-07 | |
| 5 | SUBSTANTIAL MODIFICATION | SM-7 | 2024-07-12 | Belgium | Acceptable | 2024-09-17 |
| 6 | SUBSTANTIAL MODIFICATION | SM-8 | 2024-07-12 | Acceptable | 2024-08-08 | |
| 7 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2024-09-18 | Acceptable | 2024-09-18 | |
| 8 | SUBSTANTIAL MODIFICATION | SM-10 | 2024-09-18 | Acceptable | 2024-10-11 | |
| 9 | SUBSTANTIAL MODIFICATION | SM-13 | 2024-11-29 | Belgium | Acceptable 2025-03-05
|
2025-03-05 |
| 10 | SUBSTANTIAL MODIFICATION | SM-14 | 2025-05-19 | Belgium | Acceptable with conditions 2025-08-08
|
2025-08-08 |
| 11 | SUBSTANTIAL MODIFICATION | SM-15 | 2025-08-27 | Belgium | Acceptable 2025-10-13
|
2025-10-14 |
| 12 | SUBSTANTIAL MODIFICATION | SM-16 | 2025-10-31 | Belgium | Acceptable 2026-01-28
|
2026-01-28 |
| 13 | SUBSTANTIAL MODIFICATION | SM-17 | 2026-04-30 | Belgium | Acceptable 2026-07-01
|
2026-07-01 |