A study to test a new immunotherapy, ABX-001, alone and in combination with the marketed drug, pembrolizumab, for the treatment of tumors previously treated with other therapies.

Start 3 Oct 2025 · Status Ongoing, recruiting · 2 EU/EEA countries · 5 sites · Protocol ABX-001-01

Overview

Sponsor-declared trial summary

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

Status Ongoing, recruiting

Participants planned 27

Countries 2

Sites 5

Advanced Solid Tumors Who Are Beyond Standard of Care

Key facts

Sponsor: Abalos Therapeutics GmbH
Participant type: Patients
Age range: 18-64 years, 65+ years
Gender: Male and Female
Therapeutic area: Diseases [C] - Neoplasms [C04]
Trial duration: 3 Oct 2025 → ongoing
Decision date (initial): 2025-09-30
Transition trial: No
Low-intervention: No
Rare-disease indication: No
Vulnerable population: No

Trial design

CTIS Part I — objectives, methods, condition coding

Conditions and MedDRA coding

Advanced Solid Tumors Who Are Beyond Standard of Care

Version	Level	Code	Term	System organ class
21.1	LLT	10065252	Solid tumor	10029104

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Abalos Therapeutics GmbH

Sponsor organisation: Abalos Therapeutics GmbH
Address: Merowingerplatz 1 A, Bilk Bilk
City: Duesseldorf
Postcode: 40225
Country: Germany

Scientific contact point

Organisation: Abalos Therapeutics GmbH
Contact name: Senior Director Clinical Operations

Public contact point

Organisation: Abalos Therapeutics GmbH
Contact name: Senior Director Clinical Operations

Locations

2 EU/EEA countries · 5 investigational sites

By country

Country	MS status	Planned subjects	Sites
Germany	Ongoing, recruiting	12	2
Spain	Ongoing, recruiting	15	3
Rest of world	—	0	—

Investigational sites

Germany

2 sites · Ongoing, recruiting

Universitaetsklinikum Tuebingen AöR

lnnere Medizin VIII - Medizinische Onkologie und Pneumologie, Otfried-Mueller-Strasse 10, Nordstadt, Tuebingen

Charite Universitaetsmedizin Berlin KöR

Medizinische Klinik m. S. Haematologie, Onkologie und Tumorimmunologie, Hindenburgdamm 30, Lichterfelde, Berlin

Spain

3 sites · Ongoing, recruiting

Hospital Universitario Fundacion Jimenez Diaz

Oncology, Avenida De Los Reyes Catolicos 2, 28040, Madrid

Hospital Universitario Hm Sanchinarro

Oncology, Calle Ona 10, 28050, Madrid

Hospital Universitari Vall D Hebron

Oncology, Passeig De La Vall D'Hebron 119-129, 08035, Barcelona

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
Germany	2025-12-23		2026-01-28
Spain	2025-10-03		2025-10-03

Application history

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

#	Type	Code	Submitted	Reference MS	Conclusion	Decision date
1	INITIAL	IN	2025-07-11	Germany	Acceptable 2025-09-18	2025-09-22
2	SUBSTANTIAL MODIFICATION	SM-1	2025-11-20	Germany	Acceptable	2026-01-06
3	SUBSTANTIAL MODIFICATION	SM-2	2025-11-20		Acceptable	2026-01-14