Actively Recruiting

Phase 1
Age: 18Years +
All Genders
NCT07395258

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)

Led by Boehringer Ingelheim · Updated on 2026-04-15

60

Participants Needed

10

Research Sites

306 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This study is open to adults aged 18 and over or above legal age with different types of recurrent advanced cancer (solid tumors) that have spread to other parts of the body and that are accessible for injection and biopsy. This is a study for people for whom previous treatment was not successful or no treatment exists, with a life expectancy of at least 3 months after starting study treatment. The purpose of this study is to find the highest dose of a medicine called BI 3923948, that people with advanced cancer can tolerate, when taken alone and together with a type of antibody called a checkpoint inhibitor (anti-programmed cell death protein 1 antibody). Another purpose is to check whether the study treatment can fight cancer. In this study, BI 3923948 is given to people for the first time. This study has 2 arms. In Arm A, participants get BI 3923948 alone for up to 3 months. In Arm B, participants get BI 3923948 in combination with a checkpoint inhibitor. Participants who take the combination treatment get BI 3923948 for up to 3 months and a checkpoint inhibitor for up to 1 year. BI 3923948 is given as injection(s) into the tumor, and the checkpoint inhibitor is given as an infusion into a vein. Participants get the medicines about every 3 weeks. This is called a treatment cycle. Only in treatment cycle 1 will participants get BI 3923948 twice in the first week. Participants visit the site study site regularly. The number of study visits vary based on the study arm and treatment response. Some visits include an overnight stay. The doctors regularly check the participants' health and monitor the tumors. The doctors closely check the health of the participants and also take note of any health problems that could have been caused by the study treatment.

CONDITIONS

Official Title

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)

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults aged 18 years or older
  • Measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
  • At least 1 accessible tumor lesion (2 or more preferred)
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • Life expectancy of at least 3 months after starting treatment according to investigator judgment
Not Eligible

You will not qualify if you...

  • Known primary brain tumors, leptomeningeal disease, or untreated brain metastases (stable previously treated brain metastases allowed)
  • Previous treatment with vesicular stomatitis virus (VSV)-based agents
  • Use of medications or conditions posing high risk for complications from injection
  • History of severe (grade 3 or higher) hypersensitivity reactions to previous anti-PD-1/PD-L1 antibody therapy (for combination treatment arm)

AI-Screening

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Trial Site Locations

Total: 10 locations

1

Indiana University

Indianapolis, Indiana, United States, 46202

Not Yet Recruiting

2

University of Minnesota

Minneapolis, Minnesota, United States, 55455

Actively Recruiting

3

The University of Texas MD Anderson Cancer Center

Houston, Texas, United States, 77030

Not Yet Recruiting

4

Fred Hutchinson Cancer Research Center

Seattle, Washington, United States, 98109

Not Yet Recruiting

5

CTR Leon Berard

Lyon, France, 69373

Not Yet Recruiting

6

Institut Gustave Roussy

Villejuif, France, 94800

Not Yet Recruiting

7

Universitätsklinikum Heidelberg

Heidelberg, Germany, 69120

Not Yet Recruiting

8

Hospital Clínic de Barcelona

Barcelona, Spain, 08036

Not Yet Recruiting

9

Hospital Clinico De Valencia (INCLIVA)

Valencia, Spain, 46010

Not Yet Recruiting

10

Karolinska Universitetssjukhuset Stockholm

Stockholm, Sweden, 17177

Not Yet Recruiting

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Research Team

B

Boehringer Ingelheim

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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