Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ongoing, recruitment ended
Participants planned
23
Countries
2
Sites
9
Sarcoma
Key facts
- Sponsor
- Valo Therapeutics Oy
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 7 Mar 2023 → ongoing
- Decision date (initial)
- 2024-11-08
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2024-517580-23-00
- EudraCT number
- 2021-002529-13
- ClinicalTrials.gov
- NCT05492682
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Sarcoma
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | PT | 10075566 | Triple negative breast cancer | 100000004864 |
| 21.0 | PT | 10061451 | Colorectal cancer | 100000004864 |
| 21.1 | PT | 10061873 | Non-small cell lung cancer | 100000004864 |
| 20.0 | PT | 10039491 | Sarcoma | 100000004864 |
| 21.1 | LLT | 10053571 | Melanoma | 10029104 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Valo Therapeutics Oy
- Sponsor organisation
- Valo Therapeutics Oy
- Address
- Viikinkaari 6
- City
- Helsinki
- Postcode
- 00790
- Country
- Finland
Scientific contact point
- Organisation
- Valo Therapeutics Oy
- Contact name
- Clinical Trials Information
Public contact point
- Organisation
- Valo Therapeutics Oy
- Contact name
- Clinical Trials Information
Locations
2 EU/EEA countries · 9 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Germany | Ongoing, recruitment ended | 15 | 5 |
| Italy | Ongoing, recruiting | 8 | 4 |
| Rest of world | — | 0 | — |
Investigational sites
Universitaetsmedizin Goettingen
Klinik für Dermatologie, Venerologie und Allergologie, Robert-Koch-Strasse 40, Weende, Goettingen
Universitätsklinikum Tübingen
Phase I Klinik, NET Zentrum; Abteilung Innere Medizin VIII, Phase I Klinik, NET Zentrum,, Tübingen
Krankenhaus Nordwest GmbH
Klinik für Hämatologie und Onkologie, Steinbacher Hohl 2-26, Praunheim, Frankfurt Am Main
Charite Universitaetsmedizin Berlin KöR
Charité Campus Benjamin Franklin (CBF), Comprehensive Cancer Center, Hindenburgdamm 30, Lichterfelde, Berlin
Universitaetsklinikum Heidelberg AöR
Nationales Centrum für Tumorerkrankungen (NCT) Heidelberg, Im Neuenheimer Feld 460, Neuenheim, Heidelberg
Istituto Di Candiolo Fondazione Del Piemonte Per L'Oncologia IRCCS
Medical Oncology Department, Strada Provinciale 142 Orba Km 3,95, 10060, Candiolo
Ospedale San Raffaele S.r.l.
Medical Oncology Department, Via Olgettina 60, 20132, Milan
Azienda Ospedaliera Universitaria Federico II Di Napoli
Clinical Medicine and Surgery, Via Sergio Pansini 5, 80131, Naples
Humanitas Mirasole S.p.A.
Department of Medical Oncology and Hematology, Via Alessandro Manzoni 56, 20089, Rozzano
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 | 2023-03-07 | 2023-03-07 | 2025-01-23 | ||
| Italy | 2026-04-21 | 2026-05-15 |
Application history
7 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-10-16 | Germany | Acceptable 2024-11-01
|
2024-11-08 |
| 2 | SUBSTANTIAL MODIFICATION | SM-2 | 2024-12-17 | Germany | Acceptable 2025-01-16
|
2025-01-20 |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-04-04 | Germany | Acceptable 2025-01-16
|
2025-04-04 |
| 4 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2025-07-31 | Germany | Acceptable 2025-01-16
|
2025-07-31 |
| 5 | SUBSEQUENT ADDITION OF MSC | APP-5 | 2025-08-04 | 2025-10-24 | ||
| 6 | SUBSTANTIAL MODIFICATION | SM-3 | 2026-01-30 | Germany | Acceptable 2026-04-13
|
2026-04-14 |
| 7 | NON SUBSTANTIAL MODIFICATION | NSM-3 | 2026-04-28 | Acceptable 2026-04-13
|
2026-04-28 |