A Study to Test Different Doses of BI 3968621 When Given Alone or With Ezabenlimab in Patients With Advanced Cancer

What this study involves

The registry says this study is recruiting. Individual locations may have different availability.

Study type

Interventional

Phase

Phase 1

Age range

18 years - Not specified

Sex eligible

All sexes

Healthy volunteers

Not accepted

Participants

90 Estimated

These are starting points, not an eligibility decision. The research team must review the full requirements.

About the research

This study is open to adults with advanced cancer that cannot be removed by surgery or have spread to other parts of the body. The purpose of this study is to find the highest and most suitable dose of BI 3968621 that people with advanced cancer can tolerate when taken alone or with ezabenlimab. Another purpose is to find out if taking these medicines can stop tumours from growing or make tumours shrink. In this study, BI 3968621 is given to people for the first time.

The study is done in 3 parts. The parts are called Part A, Part A2, and Part B. Participants get BI 3968621 alone or in combination with ezabenlimab depending on which part they are in. Part A is done to find the highest and the most suitable dose of BI 3968621 that people with advanced cancer can tolerate. Part A2 is done to find out if taking BI 3968621, at certain dose levels, can stop or slow down tumour growth in participants with kidney cancer. Part B is done to find out how BI 3968621 is tolerated when given with ezabenlimab. BI 3968621 is taken daily as tablets. Ezabenlimab is given as an infusion into a vein once every 3 weeks.

Participants can receive study treatment for up to 2 years if they benefit and can tolerate it. During this time, they visit the study site regularly. The number of visits depends on how participants respond to and tolerate the study treatment. Researchers look at the number of participants with certain severe health problems that happen within 3 weeks after the first study treatment. The study doctors check participants' health, take note of unwanted effects, take blood samples, and check how the cancer responds to study treatment.

Who may be able to participate?

The list below is the sponsor’s full registry wording. It can include conditions, prior treatment, test results and other requirements. A match in search does not mean you qualify.

Inclusion Criteria:

• Male and female participants ≥18 years of age and at least at the legal age of consent
• Patients with a histologically confirmed diagnosis of advanced, unresectable, and/or metastatic solid tumours (any type). Patients who have failed conventional treatment or for whom no therapy of proven efficacy exists or who are not eligible for established treatment options. Patients must have exhausted approved treatment options known to prolong survival for their disease
• At least one measurable lesion outside of central nervous system (CNS) as defined per modified Response Evaluation Criteria In Solid Tumors (RECIST) v1.1
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
• Life expectancy ≥3 months at the start of treatment in the opinion of the investigator
• Patients with known brain metastases are eligible, provided they meet the protocol-defined criteria
• Patients must have adequate organ function based on haematological, hepatic, renal, and coagulation parameters Further inclusion criteria apply.

Exclusion Criteria:

• Previous or concomitant malignancies other than the one treated in this trial within the past 3 years (except effectively treated malignancy considered cured by local treatment, e.g. non melanoma skin cancers, carcinoma in situ of the cervix, ductal carcinoma in situ)
• Patient with known leptomeningeal disease or spinal cord compression due to disease
• Patients with hepatitis C infection or active hepatitis B infection (chronic or acute)
• Patients with known history of Human immunodeficiency virus (HIV) infection who meet protocol-defined criteria
• Patient with active autoimmune disease or a documented history of autoimmune disease, which requires systemic treatment (e.g. corticosteroids or immunosuppressive drugs)
• Patient with a diagnosis of immunodeficiency other than HIV
• Manifestation of malabsorption or any other condition that could affect oral absorption, distribution or metabolism of the study drug Further exclusion criteria apply.

Treatment, groups and participation

The registry may describe treatments and study duration without a complete visit calendar. Ask the study team for the exact schedule, procedures, risks, costs and alternatives. Keep your usual care plan unless your treating clinician tells you otherwise.

Assignment

Not randomized

Masking

No masking

What researchers are measuring

Outcome measures describe what is being studied. They are not proof that a treatment works.

Primary measures

Secondary measures

Research locations (10)

The overall study status and a local site’s status can differ. Confirm that location’s availability before traveling.

10 locations

Study team and timeline

Lead sponsor

Boehringer Ingelheim

Study start

Nov 10, 2026 Estimated

Primary completion

Sep 3, 2030 Estimated

Study completion

Sep 3, 2030 Estimated

First posted

Oct 1, 2026 Actual

Last updated

Nov 10, 2026 Actual

Official study contacts