Actively Recruiting
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
Eligibility Criteria
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
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
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
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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