Clinical trial • Phase III • Oncology

BI 3819026 for Unresectable advanced or metastatic solid cancer

Phase III trial of BI 3819026 for Unresectable advanced or metastatic solid cancer. 48 participants.

Overview

Trial Therapeutic Area
Oncology
Trial Disease
Unresectable advanced or metastatic solid cancer
Trial Stage
Phase III
Drug Modality
Small molecule|Monoclonal antibody

Key dates

Initial CTIS Submission Date
09-02-2026
First CTIS Authorization Date
13-04-2026

Trial design

Phase III trial in Spain.

Target Sample Size
48

Eligibility

Recruits 48 No vulnerable population selected (isVulnerablePopulationSelected: false); no assent/consent handling details provided in the record..

Vulnerable Population
No vulnerable population selected (isVulnerablePopulationSelected: false); no assent/consent handling details provided in the record.

Recruitment

Planned Sample Size
48
Recruitment Window Months
45
Consent Approach
Not specified in record; no details provided on who provides consent, assent, age-specific documents or languages.

Geography

Total Number Of Sites
3
Total Number Of Participants
48

Spain

Earliest CTIS Part Ii Submission Date
09-03-2026
Latest Decision Or Authorization Date
13-04-2026
Processing Time Days
35
Number Of Sites
3
Number Of Participants
12

Sites

Site Name
Hospital Universitari Vall D Hebron
Department Name
Servicio oncología y hematología
Contact Person Name
Victoria Sánchez
Contact Person Email
victoriasanchez@vhio.net
Site Name
Clinica Universidad De Navarra
Department Name
Unidad central de Ensayos Clínicos
Contact Person Name
Ignacio Melero
Contact Person Email
imelero@unav.es
Site Name
Hospital Clinico Universitario De Valencia
Department Name
Servicio de Hematologia y Oncologia, INCLIVA. Edificio Maternidad.
Contact Person Name
Valentina Gambardella
Contact Person Email
valen.gambardella@gmail.com

Sponsor

Primary sponsor

Full Name
Boehringer Ingelheim International GmbH
Organisation Type
Pharmaceutical company
Country Of Registered Address
Germany

Third parties

  • {"country":"Spain","full_name":"Boehringer Ingelheim Espana S.A.","duties_or_roles":"","organisation_type":"Pharmaceutical company"}

Investigational products

Investigational Product Name
BI 3819026
Modality
Small molecule
Investigational Product Name
ezabenlimab
Modality
Monoclonal antibody
Combination Treatment
Yes

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