A Study to Test Different Doses of BI 3923948 Alone and in Combination With an Anti-PD-1 Antibody… (NCT07395258) | Clinical Trial Compass
SuspendedPhase 1
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)
Stopped: Temporary enrolment hold as a precautionary measure following a safety event in a related trial
United States60 participantsStarted 2026-04-02
Plain-language summary
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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Measurable disease as defined per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.
. Patient has 1 or more accessible lesions (2 or more preferred)
. Eastern Cooperative Oncology Group (ECOG) score of 0 or 1
. Life expectancy of at least ≥3 months after the start of the treatment according to the investigator's judgement Further inclusion criteria apply.
Exclusion criteria
. Patients with known primary brain tumors, leptomeningeal disease or untreated brain metastases. Subjects with previously treated brain metastases may participate provided the brain metastases are stable
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Occurrence of Dose-limiting toxicities (DLTs) during the primary DLT evaluation period
. Previous treatment with vesicular stomatitis virus (VSV)-based agents
. Concomitant medication or condition considered a high risk for complications from injection
. History of common terminology criteria for adverse events (CTCAE) v5 grade 3 or higher severe hypersensitivity reactions to previous anti-programmed cell death 1 (anti-PD-1)/anti-programmed cell death ligand 1 (PD-L1) monoclonal antibody (mAb) (Arm B only) Further exclusion criteria apply.