A First-in-Human clinical trial assessing safety of ES2B-C001 with or without Montanide in patients with HER2 expressing metastatic breast cancer.

Start 16 Dec 2024 · Status Ongoing, recruiting · 1 EU/EEA countries · 3 sites · Protocol ES2B-C001-S01

Overview

Sponsor-declared trial summary

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

Status Ongoing, recruiting

Participants planned 40

Countries 1

Sites 3

HER2 positive patients under HER2 maintenance therapy (metastatic or locally advanced, unresectable)

Key facts

Sponsor: Expres2ion Biotechnologies ApS
Participant type: Patients
Age range: 18-64 years, 65+ years
Gender: Male and Female
Therapeutic area: Diseases [C] - Neoplasms [C04]
Trial duration: 16 Dec 2024 → ongoing
Decision date (initial): 2024-12-02
Transition trial: No
Low-intervention: No
Rare-disease indication: No
Vulnerable population: Yes

Trial design

CTIS Part I — objectives, methods, condition coding

Conditions and MedDRA coding

HER2 positive patients under HER2 maintenance therapy (metastatic or locally advanced, unresectable)

Version	Level	Code	Term	System organ class
23.0	PT	10065430	HER2 positive breast cancer	100000004864

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Expres2ion Biotechnologies ApS

Sponsor organisation: Expres2ion Biotechnologies ApS
Address: Agern Alle 1
City: Hoersholm
Postcode: 2970
Country: Denmark

Scientific contact point

Organisation: Expres2ion Biotechnologies ApS
Contact name: Thomas K. Jorgensen

Public contact point

Organisation: Expres2ion Biotechnologies ApS
Contact name: Bent U. Frandsen

Locations

1 EU/EEA country · 3 investigational sites

By country

Country	MS status	Planned subjects	Sites
Austria	Ongoing, recruiting	40	3
Rest of world	—	0	—

Investigational sites

Austria

3 sites · Ongoing, recruiting

Medical University Of Graz

Division of Oncology, Neue Stiftingtalstrasse 6, 8010, Graz

Medical University Of Vienna

Department of Clinical Pharmacology, Waehringer Guertel 18-20, Alsergrund, Vienna

Ordensklinikum Linz GmbH

Department of Internal Medicine I, Seilerstaette 4, 4010, Linz

Country notifications

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

Country	Trial start	Trial end	Recruitment start	Recruitment end	Early termination
Austria	2024-12-16		2025-06-03

Application history

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

#	Type	Code	Submitted	Reference MS	Conclusion	Decision date
1	INITIAL	IN	2024-08-06	Austria	Acceptable 2024-11-25	2024-12-02
2	SUBSTANTIAL MODIFICATION	SM-1	2025-05-13	Austria	Acceptable 2025-06-05	2025-06-30
3	SUBSTANTIAL MODIFICATION	SM-2	2026-02-09	Austria	Acceptable 2026-03-24	2026-03-27