Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Authorised, recruiting
Participants planned
37
Countries
2
Sites
9
Newly diagnosed and/or previously treated IDH1-mutated malignancies
Key facts
- Sponsor
- Institut De Recherches Internationales Servier IRIS
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 10 Dec 2025 → ongoing
- Decision date (initial)
- 2025-11-24
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Newly diagnosed and/or previously treated IDH1-mutated malignancies
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.0 | LLT | 10049280 | Solid tumour | 10029104 |
| 27.1 | LLT | 10066481 | Hematological malignancy | 10029104 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Institut De Recherches Internationales Servier IRIS
- Sponsor organisation
- Institut De Recherches Internationales Servier IRIS
- Address
- 22 Route 128
- City
- Gif Sur Yvette
- Postcode
- 91190
- Country
- France
Scientific contact point
- Organisation
- Institut De Recherches Internationales Servier IRIS
- Contact name
- Clinical Studies Department
Public contact point
- Organisation
- Institut De Recherches Internationales Servier IRIS
- Contact name
- Clinical Studies Department
Locations
2 EU/EEA countries · 9 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Czechia | Authorised, recruiting | 12 | 4 |
| Spain | Ongoing, recruiting | 13 | 5 |
| Rest of world
Korea, Republic of, United States, United Kingdom, Australia, Brazil
|
— | 12 | — |
Investigational sites
Fakultni Nemocnice Ostrava
Klinika hematoonkologie FNO a LF OU, 17. Listopadu 1790/5, Poruba, Ostrava
Fakultni Nemocnice Brno
Interni hematologicka a onkologicka klinika, Jihlavska 340/20, Bohunice, Brno
Fakultni Nemocnice V Motole
Onkologicke oddeleni, V Uvalu 84/1, Motol, Prague
Vseobecna Fakultni Nemocnice V Praze
I. Interni klinika – klinika hematologie, U Nemocnice 499/2, Nove Mesto, Prague
Hospital Hm Nou Delfos
Oncology, Avinguda De Vallcarca 151, 08023, Barcelona
Hospital Universitario 12 De Octubre
Oncology, Avenida De Cordoba Sn, 28041, Madrid
Hospital Universitario Fundacion Jimenez Diaz
Oncology, Avenida De Los Reyes Catolicos 2, 28040, Madrid
Hospital Universitario Hm Sanchinarro
Oncology, Calle Ona 10, 28050, Madrid
Hospital Universitari Vall D Hebron
Oncology, Passeig De La Vall D'Hebron 119-129, 08035, 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 |
|---|---|---|---|---|---|
| Czechia | 2026-01-19 | ||||
| Spain | 2025-12-10 | 2026-01-14 |
Application history
3 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-08-05 | Spain | Acceptable 2025-11-20
|
2025-11-24 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-12-03 | Acceptable | 2026-01-13 | |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2026-02-25 | Spain | Acceptable | 2026-03-16 |