First study evaluating the safety and dosage of YG-01 in patients with a malignant brain tumor

2025-524299-44-00 Protocol YG-01-101 Human pharmacology (Phase I) - First administration to humans Authorised, recruitment pending

Status Authorised, recruitment pending · 1 EU/EEA countries · 1 sites · Protocol YG-01-101

Overview

Sponsor-declared trial summary

Phase Human pharmacology (Phase I) - First administration to humans
Status Authorised, recruitment pending
Participants planned 15
Countries 1
Sites 1

Glioblastoma

Key facts

Sponsor
Ygion Biomedical GmbH
Participant type
Patients
Age range
18-64 years, 65+ years
Gender
Male and Female
Therapeutic area
Diseases [C] - Neoplasms [C04]
Decision date (initial)
2026-06-29
Transition trial
No
Low-intervention
No
Rare-disease indication
No
Vulnerable population
Yes

External identifiers

EU CT number
2025-524299-44-00
WHO UTN
U1111-1330-5924

Trial design

CTIS Part I — objectives, methods, condition coding

Conditions and MedDRA coding

Glioblastoma

VersionLevelCodeTermSystem organ class
20.0 PT 10018336 Glioblastoma 100000004864

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Ygion Biomedical GmbH

Sponsor organisation
Ygion Biomedical GmbH
Address
Campus Biocenter 5, U-Bahn Station Wien-Mitte Landstrasse 0, Landstrasse U-Bahn Station Wien-Mitte Landstrasse 0 Landstrasse
City
Vienna
Postcode
1030
Country
Austria

Scientific contact point

Organisation
Ygion Biomedical GmbH
Contact name
Clinical Trial Division

Public contact point

Organisation
Ygion Biomedical GmbH
Contact name
Clinical Trial Division

Locations

1 EU/EEA country · 1 investigational sites

By country

CountryMS statusPlanned subjectsSites
Austria Authorised, recruitment pending 15 1
Rest of world 0

Investigational sites

Austria

1 site · Authorised, recruitment pending
Medical University Of Vienna
Department of Medicine I, Division of Oncology, Waehringer Guertel 18-20, Alsergrund, Vienna

Application history

1 submissions — initial application plus substantial / non-substantial modifications

#TypeCodeSubmittedReference MSConclusionDecision date
1 INITIAL IN 2026-03-05 Austria Acceptable
2026-06-22
2026-06-29