A study to test different doses of BI 3923948 alone and in combination with an anti-PD-1 antibody in people with different types of advanced cancer (solid tumors)

Status Authorised, recruitment pending · 4 EU/EEA countries · 6 sites · Protocol 1538-0001

Overview

Sponsor-declared trial summary

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

Status Authorised, recruitment pending

Participants planned 50

Countries 4

Sites 6

advanced, unresectable and/or metastatic solid tumors

Key facts

Sponsor: Boehringer Ingelheim International GmbH, Boehringer Ingelheim Espana S.A.
Participant type: Patients
Age range: 18-64 years, 65+ years
Gender: Male and Female
Therapeutic area: Diseases [C] - Neoplasms [C04]
Decision date (initial): 2026-02-22
Transition trial: No
Low-intervention: No
Rare-disease indication: No
Vulnerable population: No

External identifiers

EU CT number: 2025-521438-27-00
WHO UTN: U1111-1319-8046

Trial design

CTIS Part I — objectives, methods, condition coding

Conditions and MedDRA coding

advanced, unresectable and/or metastatic solid tumors

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Boehringer Ingelheim International GmbH

Sponsor organisation: Boehringer Ingelheim International GmbH
Address: Binger Strasse 173
City: Ingelheim Am Rhein
Postcode: 55216
Country: Germany

Scientific contact point

Organisation: Boehringer Ingelheim International GmbH
Contact name: CT Disclosure & Data Transparency

Public contact point

Organisation: Boehringer Ingelheim International GmbH
Contact name: CT Disclosure & Data Transparency

Boehringer Ingelheim Espana S.A.

Sponsor organisation: Boehringer Ingelheim Espana S.A.
Address: Carrer Prat De La Riba 50, Sant Cugat Del Valles Sant Cugat Del Valles
City: Barcelona
Postcode: 08174
Country: Spain

Locations

4 EU/EEA countries · 6 investigational sites

By country

Country	MS status	Planned subjects	Sites
France	Authorised, recruitment pending	10	2
Germany	Authorised, recruitment pending	5	1
Spain	Authorised, recruitment pending	15	2
Sweden	Authorised, recruitment pending	5	1
Rest of world United States	—	15	—

Investigational sites

France

2 sites · Authorised, recruitment pending

Centre Leon Berard

Service d'oncologie médicale, 28 Rue Laennec, 69008, Lyon

Institut Gustave Roussy

Département de Médecine Comité OS – partie Molles, 114 Rue Edouard Vaillant, 94800, Villejuif

Germany

1 site · Authorised, recruitment pending

Universitaetsklinikum Heidelberg AöR

Nationales Centrum für Tumorerkrankungen (NCT), Im Neuenheimer Feld 460, Neuenheim, Heidelberg

Spain

2 sites · Authorised, recruitment pending

Instituto De Investigacion Sanitaria Fundacion Para La Investigacion Del Hospital Clinico De Valencia-INCLIVA

Servicio de Hematología y Oncología, Avenida Menendez Y Pelayo 4, 46010, Valencia

Hospital Clinic De Barcelona

Servicio de Oncología Médica, Calle Villarroel 170, 08036, Barcelona

Sweden