A study to investigate how a single dose of the drug melflufen reaches brain tumor tissue, and how it affects the tumour, in patients who are already scheduled for surgery for a returning glioblastoma

2026-525543-32-00 Protocol OP-701 Human pharmacology (Phase I) - Other Authorised, recruiting

Start 17 Jun 2026 · Status Authorised, recruiting · 1 EU/EEA countries · 1 sites · Protocol OP-701

Overview

Sponsor-declared trial summary

Phase Human pharmacology (Phase I) - Other
Status Authorised, recruiting
Participants planned 10
Countries 1
Sites 1

Recurrent glioblastoma

Key facts

Sponsor
Oncopeptides AB
Participant type
Patients
Age range
18-64 years, 65+ years
Gender
Male and Female
Therapeutic area
Diseases [C] - Nervous System Diseases [C10], Diseases [C] - Neoplasms [C04]
Trial duration
17 Jun 2026 → ongoing
Decision date (initial)
2026-05-15
Transition trial
No
Low-intervention
No
Rare-disease indication
Yes
Vulnerable population
No

Trial design

CTIS Part I — objectives, methods, condition coding

Conditions and MedDRA coding

Recurrent glioblastoma

VersionLevelCodeTermSystem organ class
20.0 PT 10018336 Glioblastoma 100000004864

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Oncopeptides AB

Sponsor organisation
Oncopeptides AB
Address
7th Floor, Luntmakargatan 46, Adolf Fredrik Luntmakargatan 46 Adolf Fredrik
City
Stockholm
Postcode
111 37
Country
Sweden

Scientific contact point

Organisation
Oncopeptides AB
Contact name
Stefan Norin

Public contact point

Organisation
Oncopeptides AB
Contact name
Eva Nordström

Locations

1 EU/EEA country · 1 investigational sites

By country

CountryMS statusPlanned subjectsSites
Norway Authorised, recruiting 10 1
Rest of world 0

Investigational sites

Norway

1 site · Authorised, recruiting
Oslo Universitetssykehus HF
Department of Oncology, Montebello, Ullernchausséen 70, Oslo

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Country Trial startTrial end Recruitment startRecruitment end Early termination
Norway 2026-06-17

Application history

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

#TypeCodeSubmittedReference MSConclusionDecision date
1 INITIAL IN 2026-03-13 Norway Acceptable
2026-05-15
2026-05-15