Actively Recruiting
A Study to Find the Highest Dose of BI 3819026 Alone and With Ezabenlimab in Adults With Advanced or Metastatic Solid Cancers
Led by Boehringer Ingelheim · Updated on 2026-05-29
60
Participants Needed
9
Research Sites
123 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the highest dose of BI 3819026 that adults with advanced or metastatic solid cancers can tolerate when taken alone and together with ezabenlimab. This study focuses on patients whose cancer has progressed despite available treatments or who are ineligible for standard therapies. The goal is to find a safe dose for further testing, with participants having confirmed measurable tumors outside the brain. Some patients with stable brain metastases may also join under specific conditions. Participants first receive a single treatment of BI 3819026 alone at increasing dose levels, starting from the lowest dose. If tolerated, they then receive combined treatment with BI 3819026 and ezabenlimab at the same dose level. Different small groups of participants receive escalating doses of BI 3819026 in this dose escalation phase. Each participant stays on their assigned dose throughout the study, which lasts up to two years unless their condition worsens or they cannot tolerate the treatment. During the study, participants visit the study site regularly for monitoring. Doctors check for dose-limiting toxicities and other adverse effects, take blood samples, and perform tumor imaging to track changes. They also evaluate treatment effects on target cells compared to baseline. Safety and treatment tolerability are carefully assessed throughout the on-treatment period, lasting up to two years.
CONDITIONS
Brief Title
A Study in People With Advanced Cancer to Test How Well Different Doses of BI 3819026 Are Tolerated When Taken Alone and Together With Ezabenlimab
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults with histologically confirmed unresectable advanced or metastatic solid tumors
- Disease progressed after or refractory to standard therapies, or ineligible for them
- At least one measurable tumor lesion outside the central nervous system
- Stable and treated brain metastases allowed under defined conditions
- Availability of archived tumor tissue or agreement for enrollment without it
- Toxicities from prior cancer treatments resolved to Grade 1 or baseline except specific exceptions
- Adequate liver, bone marrow, and kidney function
- Further inclusion criteria apply
You will not qualify if you...
- Other malignancies within the last 3 years except effectively treated non-melanoma skin cancer, carcinoma in situ of cervix or breast, or other cured malignancies
- Prior immune-checkpoint inhibitor therapy stopped due to immune-related adverse events
- Anti-cancer systemic drugs within 3 weeks or 5 half-lives before trial treatment
- Radiotherapy within 4 weeks prior to treatment except defined palliative radiotherapy
- Active or past interstitial lung disease, pulmonary fibrosis, organizing pneumonia, or non-infectious pneumonitis
- Active autoimmune disease requiring systemic treatment, with some exceptions
- Diagnosed immunodeficiency other than HIV
- HIV patients excluded if CD4+ count below 350 cells/µL, viral load above 400 copies/mL, or other specified criteria
- Further exclusion criteria apply
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 30 days for primary dose-limiting toxicity evaluation; treatment and observation may continue up to 2 years
Participants receive different doses of BI 3819026 alone and together with Ezabenlimab to test how well these doses are tolerated.
Visits occur during treatment cycles, including assessments in Cycle 1 and Cycle 3; frequency varies by dose group
Trial Site Locations
Total: 9 locations
1
Yale Cancer Center
New Haven, Connecticut, United States, 06511
Not Yet Recruiting
2
Hackensack University Medical Center
Hackensack, New Jersey, United States, 07601
Not Yet Recruiting
3
New York University Langone Medical Center
New York, New York, United States, 10016
Not Yet Recruiting
4
SCRI Oncology Partners
Nashville, Tennessee, United States, 37203
Not Yet Recruiting
5
National Cancer Center Hospital East
Chiba, Kashiwa, Japan, 277-8577
Not Yet Recruiting
6
National Cancer Center Hospital
Tokyo, Chuo-ku, Japan, 104-0045
Actively Recruiting
7
Hospital Universitari Vall d'Hebron
Barcelona, Spain, 08035
Not Yet Recruiting
8
Clínica Universidad de Navarra
Pamplona, Spain, 31008
Not Yet Recruiting
9
Hospital Clinico Universitario de Valencia
Valencia, Spain, 46010
Actively Recruiting
Research Team
B
Boehringer Ingelheim
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
8
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