Glioblastoma · Phase I (2024-515128-35-00)

Status Authorised, recruitment pending · 2 EU/EEA countries · 4 sites · Protocol DBP-053-01

Overview

Sponsor-declared trial summary

Phase Human pharmacology (Phase I) - First administration to humans

Status Authorised, recruitment pending

Participants planned 27

Countries 2

Sites 4

Glioblastoma

Key facts

Sponsor: Double Bond Pharmaceutical AB
Participant type: Patients
Age range: 18-64 years
Gender: Male and Female
Therapeutic area: Diseases [C] - Neoplasms [C04]
Decision date (initial): 2024-09-11
Transition trial: Yes
Low-intervention: No
Rare-disease indication: Yes
Vulnerable population: No

External identifiers

EU CT number: 2024-515128-35-00
EudraCT number: 2021-000928-35
ClinicalTrials.gov: NCT04967690

Trial design

CTIS Part I — objectives, methods, condition coding

Conditions and MedDRA coding

Glioblastoma

Version	Level	Code	Term	System organ class
20.0	PT	10018336	Glioblastoma	100000004864

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Double Bond Pharmaceutical AB

Sponsor organisation: Double Bond Pharmaceutical AB
Address: Virdings Alle 32b, Vaksala Vaksala
City: Uppsala
Postcode: 754 50
Country: Sweden

Scientific contact point

Organisation: Double Bond Pharmaceutical AB
Contact name: Igor Lokot

Public contact point

Organisation: Double Bond Pharmaceutical AB
Contact name: Igor Lokot

Locations

2 EU/EEA countries · 4 investigational sites

By country

Country	MS status	Planned subjects	Sites
Germany	Authorised, recruitment pending	21	3
Netherlands	Authorised, recruitment pending	6	1
Rest of world	—	0	—

Investigational sites

Germany

3 sites · Authorised, recruitment pending

University Hospital Cologne AöR

Center for Neurosurgery, Kerpener Strasse 62, Lindenthal, Cologne

University Medical Center Hamburg-Eppendorf

Neurosurgery, Martinistrasse 52, Eppendorf, Hamburg

Universitaetsklinikum Aachen AöR

Clinic for Neurosurgery, Pauwelsstrasse 30, 52074, Aachen

Netherlands

1 site · Authorised, recruitment pending

Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)

Department of Neurosurgery, Dr. Molewaterplein 40, 3015 GD, Rotterdam

Application history

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

#	Type	Code	Submitted	Reference MS	Conclusion	Decision date
1	INITIAL	IN	2024-08-09	Germany	Acceptable 2024-09-10	2024-09-11