Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ongoing, recruiting
Participants planned
361
Countries
5
Sites
25
Advanced Malignancies
Key facts
- Sponsor
- Invox Pharma Limited
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 3 Dec 2020 → ongoing
- Decision date (initial)
- 2025-03-28
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2024-514010-12-00
- EudraCT number
- 2020-003021-28
- ClinicalTrials.gov
- NCT04740424
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Advanced Malignancies
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.0 | LLT | 10048683 | Advanced cancer | 10029104 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Invox Pharma Limited
- Sponsor organisation
- Invox Pharma Limited
- Address
- Suite 2, First Floor Westworks Wood Lane, White City Place First Floor Westworks Wood Lane White City Place
- City
- London
- Postcode
- W12 7FQ
- Country
- United Kingdom
Scientific contact point
- Organisation
- Invox Pharma Limited
- Contact name
- invoX Pharma Clinical Trials
Public contact point
- Organisation
- Invox Pharma Limited
- Contact name
- invoX Pharma Clinical Trials
Locations
5 EU/EEA countries · 25 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Germany | Ongoing, recruiting | 30 | 4 |
| Netherlands | Ongoing, recruiting | 12 | 3 |
| Poland | Ongoing, recruiting | 12 | 4 |
| Romania | Ongoing, recruiting | 35 | 2 |
| Spain | Ongoing, recruiting | 234 | 12 |
| Rest of world
Georgia, Australia
|
— | 38 | — |
Investigational sites
Universitaetsklinikum Essen AöR
Klinik für Dermatologie, Venerologie und Allergologie, Hufelandstrasse 55, Holsterhausen, Essen
SLK-Kliniken Heilbronn GmbH
Klinikum am Gesundbrunnen, Am Gesundbrunnen 20-26, Neckargartach, Heilbronn
Charite Universitaetsmedizin Berlin KöR
Early Clinical Trial Unit (ECTU), Hindenburgdamm 30, Lichterfelde, Berlin
Technische Universitaet Dresden
Medizinische Fakultät Carl Gustav Carus Nationales Centrum für Tumorerkrankungen Dresden (NCT/UCC), Fetscherstrasse 74, Johannstadt-Nord, Dresden
Radboud universitair medisch centrum Stichting
Medische Oncologie, Geert Grooteplein Zuid 10, 6525 GA, Nijmegen
Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis Stichting
Medische Oncologie, Plesmanlaan 121, 1066 CX, Amsterdam
Leids Universitair Medisch Centrum (LUMC)
Medische Oncologie, Albinusdreef 2, 2333 ZA, Leiden
Biokinetica S.A.
n/a, Ul. Nadwislanska 37, 05-410, Jozefow
Pratia S.A.
n/a, Ul. Pana Tadeusza 2, 30-727, Cracow
Pratia Hematologia Sp. z o.o.
n/a, Ul. Tadeusza Kosciuszki 92, 40-519, Katowice
Pratia S.A.
n/a, Ul. Gryfinska 1, 60-192, Poznan
Institute Of Oncology Prof. Dr. Ion Chiricuta Cluj-Napoca
Phase 1 Unit, Radiotherapy, Strada Republicii 34-36, 400015, Cluj-Napoca
Institutul Oncologic Prof. Dr. Alexandru Trestioreanu Bucuresti
Phase 1 Unit, Medical Oncology II, Radiotherapy I, Soseaua Fundeni 252, 022328, Bucharest
Clinica Universidad De Navarra
Medical Oncology Department, Avenue Pio XII 36, 31008, Pamplona
Hospital Clinic De Barcelona
Medical Oncology Department, Calle Villarroel 170, 08036, Barcelona
Complejo Hospitalario Universitario Insular Materno Infantil
Medical Oncology Department, Autovia Del Sur S/n, 35017, Las Palmas De Gran Canaria
Hospital Clinico Universitario De Valencia
Medical Oncology Department, Avenida Blasco Ibanez 17, 46010, Valencia
Hospital Universitario Quironsalud Madrid
Medical Oncology Department, Calle De Diego De Velazquez 1, 28223, Pozuelo De Alarcon
Hospital Universitario Fundacion Jimenez Diaz
Medical Oncology Department, Avenida De Los Reyes Catolicos 2, 28040, Madrid
Hospital Universitario Puerta De Hierro De Majadahonda
Medical Oncology Department, Calle De Joaquin Rodrigo 2, 28222, Majadahonda
Institut Catala D'oncologia
Medical Oncology Department, Carretera Canyet S/n, 08916, Badalona
Hospital Universitario Virgen De La Macarena
Medical Oncology Department, Avenida Del Doctor Fedriani 3, 41009, Sevilla
Hospital Universitari Vall D Hebron
Medical Oncology Department, Passeig De La Vall D'Hebron 119-129, 08035, Barcelona
Hospital Quironsalud Barcelona
Medical Oncology Department, Placa D'alfonso Comin 5-7, 08023, Barcelona
Hospital Universitario 12 De Octubre
Medical Oncology Department, Bloque D, Avenida De Cordoba Sn, 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 |
|---|---|---|---|---|---|
| Germany | 2025-06-25 | 2025-07-10 | |||
| Netherlands | 2025-05-27 | 2025-06-11 | |||
| Poland | 2025-05-06 | 2025-05-14 | |||
| Romania | 2022-12-12 | 2023-08-02 | |||
| Spain | 2020-12-03 | 2020-12-29 |
Application history
7 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-05-29 | Spain | Acceptable 2024-06-17
|
2024-06-17 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-09-06 | Spain | Acceptable 2024-11-07
|
2024-11-07 |
| 3 | SUBSEQUENT ADDITION OF MSC | APP-3 | 2025-01-08 | 2025-04-02 | ||
| 4 | SUBSEQUENT ADDITION OF MSC | APP-4 | 2025-01-09 | Acceptable 2024-11-07
|
2025-03-28 | |
| 5 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-01-09 | Spain | Acceptable | 2025-02-11 |
| 6 | SUBSEQUENT ADDITION OF MSC | APP-6 | 2025-01-10 | Acceptable 2024-11-07
|
2025-04-06 | |
| 7 | SUBSTANTIAL MODIFICATION | SM-3 | 2025-11-19 | Spain | Acceptable 2026-02-25
|
2026-02-26 |