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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.
Primary outcome measure(s)
Occurrence of dose-limiting toxicities (DLTs) during the primary DLT evaluation period (Dose escalation part A and B) — During the first treatment cycle, up to 21 days
Objective response (OR) — Up to 2 years defined as best overall response (BOR) of confirmed complete response (CR) or confirmed partial response (PR), where BOR is determined by investigator's assessment according to Response Evaluation Criteria In Solid Tumours (RECIST) v1.1 from first administration until earliest of disease progression, death or last evaluable tumour assessment before start of subsequent anticancer therapy, lost to follow-up, or withdrawal of consent, whichever occurs first (Part A2)
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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