EPITOME-1015-I: A phase I study to investigate the safety and tolerability of MDG1015 in patients with epithelial ovarian cancer, gastroesophageal adenocarcinoma, round cell liposarcoma and/or synovial sarcoma

Status Authorised, recruitment pending · 1 EU/EEA countries · 2 sites · Protocol CD-TCR-004

Overview

Sponsor-declared trial summary

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

Status Authorised, recruitment pending

Participants planned 55

Countries 1

Sites 2

Epithelial Ovarian Carcinoma

Key facts

Sponsor: Medigene AG
Participant type: Patients
Age range: 18-64 years, 65+ years
Gender: Male and Female
Therapeutic area: Diseases [C] - Neoplasms [C04]
Decision date (initial): 2025-04-01
Transition trial: No
Low-intervention: No
Rare-disease indication: No
Vulnerable population: Yes

External identifiers

EU CT number: 2024-516787-28-00
ClinicalTrials.gov: NCT06748872

Trial design

CTIS Part I — objectives, methods, condition coding

Conditions and MedDRA coding

Epithelial Ovarian Carcinoma

Version	Level	Code	Term	System organ class
20.0	PT	10042863	Synovial sarcoma	100000004864
21.1	LLT	10033131	Ovarian carcinoma	10029104
21.1	LLT	10066354	Adenocarcinoma of the gastroesophageal junction	10029104
20.0	PT	10073137	Myxoid liposarcoma	100000004864

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Medigene AG

Sponsor organisation: Medigene AG
Address: Lochhamer Strasse 11/15, Martinsried Martinsried
City: Planegg
Postcode: 82152
Country: Germany

Scientific contact point

Organisation: Medigene AG
Contact name: VP, Head of Clinical Development

Public contact point

Organisation: Medigene AG
Contact name: VP Investor Relations and Corporate Communications

Locations

1 EU/EEA country · 2 investigational sites

By country

Country	MS status	Planned subjects	Sites
Netherlands	Authorised, recruitment pending	20	2
Rest of world United States	—	35	—

Investigational sites

Netherlands

2 sites · Authorised, recruitment pending

Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis Stichting

Medical Oncology, Plesmanlaan 121, 1066 CX, Amsterdam

Universitair Medisch Centrum Groningen

Medical Oncology, Hanzeplein 1, 9713 GZ, Groningen

Application history

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

#	Type	Code	Submitted	Reference MS	Conclusion	Decision date
1	INITIAL	IN	2024-11-28	Netherlands	Acceptable 2025-03-31	2025-04-01