Clinical trial • Phase I • Oncology

BI 3923948 for Advanced unresectable or metastatic solid tumors

Phase I trial of BI 3923948 for Advanced unresectable or metastatic solid tumors. 35 participants.

Overview

Trial Therapeutic Area
Oncology
Trial Disease
Advanced unresectable or metastatic solid tumors
Trial Stage
Phase I
Drug Modality
Other | Monoclonal antibody

Key dates

Initial CTIS Submission Date
27-08-2025
First CTIS Authorization Date
19-02-2026

Trial design

Phase I trial across 6 sites in France, Germany, Spain and others.

Single Multiple Or Escalation Dose Combined
Yes
Target Sample Size
35

Recruitment

Planned Sample Size
35
Recruitment Window Months
73

Geography

Total Number Of Sites
6
Total Number Of Participants
35

France

Earliest CTIS Part Ii Submission Date
18-11-2025
Latest Decision Or Authorization Date
06-03-2026
Processing Time Days
108
Number Of Sites
2
Number Of Participants
10

Sites

Site Name
Centre Leon Berard
Department Name
Service d'oncologie médicale
Principal Investigator Name
Hélène Vanacker
Principal Investigator Email
helene.vanacker@lyon.unicancer.fr
Contact Person Name
Hélène Vanacker
Site Name
Institut Gustave Roussy
Department Name
Département de Médecine Comité OS – partie Molles
Principal Investigator Name
Rastislav Bahleda
Principal Investigator Email
rastilav.bahleda@gustaveroussy.fr
Contact Person Name
Rastislav Bahleda

Germany

Earliest CTIS Part Ii Submission Date
27-11-2025
Latest Decision Or Authorization Date
19-02-2026
Processing Time Days
84
Number Of Sites
1
Number Of Participants
5

Sites

Site Name
Universitaetsklinikum Heidelberg AöR
Department Name
Nationales Centrum für Tumorerkrankungen (NCT)
Principal Investigator Name
Guy Ungerechts
Principal Investigator Email
guy.ungerechts@nct-heidelberg.de
Contact Person Name
Guy Ungerechts

Spain

Earliest CTIS Part Ii Submission Date
10-10-2025
Latest Decision Or Authorization Date
19-02-2026
Processing Time Days
132
Number Of Sites
2
Number Of Participants
15

Sites

Site Name
Instituto De Investigacion Sanitaria Fundacion Para La Investigacion Del Hospital Clinico De Valencia-INCLIVA
Department Name
Servicio de Hematología y Oncología
Principal Investigator Name
Valentina Gambardella
Principal Investigator Email
valen.gambardella@gmail.com
Contact Person Name
Valentina Gambardella
Contact Person Email
valen.gambardella@gmail.com
Site Name
Hospital Clinic De Barcelona
Department Name
Servicio de Oncología Médica
Principal Investigator Name
Iván Victoria Ruiz
Principal Investigator Email
ivictori@recerca.clinic.cat
Contact Person Name
Iván Victoria Ruiz
Contact Person Email
ivictori@recerca.clinic.cat

Sweden

Earliest CTIS Part Ii Submission Date
21-11-2025
Latest Decision Or Authorization Date
20-02-2026
Processing Time Days
91
Number Of Sites
1
Number Of Participants
5

Sites

Site Name
Karolinska University Hospital
Department Name
Department of Clinical Cancer Studies Cancer Theme
Principal Investigator Name
Maximilian Kordes
Principal Investigator Email
maximilian.kordes@regionstockholm.se
Contact Person Name
Maximilian Kordes

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 3923948
Modality
Other
Investigational Product Name
anti-PD-1 antibody
Modality
Monoclonal antibody
Combination Treatment
Yes

Related trials

Other published trials that may interest you.