Clinical trial • Phase I • Oncology

MDG1015 for Epithelial ovarian carcinoma | Myxoid (round cell) liposarcoma | Gastroesophageal junction adenocarcinoma | Synovial sarcoma

Phase I trial of MDG1015 for Epithelial ovarian carcinoma | Myxoid (round cell) liposarcoma | Gastroesophageal junction adenocarcinoma | Synovial sarcoma.

Overview

Trial Therapeutic Area
Oncology
Trial Disease
Epithelial ovarian carcinoma | Myxoid (round cell) liposarcoma | Gastroesophageal junction adenocarcinoma | Synovial sarcoma
Trial Stage
Phase I

Key dates

Initial CTIS Submission Date
28-11-2024
First CTIS Authorization Date
01-04-2025

Trial design

Phase I trial across 2 sites in Netherlands.

Target Sample Size
35

Eligibility

Recruits 35 Vulnerable population selected; no further details on consent or assent handling provided in the record..

Vulnerable Population
Vulnerable population selected; no further details on consent or assent handling provided in the record.

Recruitment

Planned Sample Size
35
Recruitment Window Months
204

Geography

Total Number Of Sites
2
Total Number Of Participants
20

Netherlands

Earliest CTIS Part Ii Submission Date
26-03-2025
Latest Decision Or Authorization Date
01-04-2025
Processing Time Days
6
Number Of Sites
2
Number Of Participants
20

Sites

Site Name
Universitair Medisch Centrum Groningen
Department Name
Medical Oncology
Contact Person Name
Mathilde Jalving
Contact Person Email
m.jalving@umcg.nl
Site Name
Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis Stichting
Department Name
Medical Oncology
Contact Person Name
Sebastian Klobuch
Contact Person Email
s.klobuch@nki.nl

Sponsor

Primary sponsor

Full Name
Medigene AG
Organisation Type
Pharmaceutical company
Country Of Registered Address
Germany

Investigational products

Investigational Product Name
MDG1015

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