Actively Recruiting
A Study of BI 3810944 in Patients With Advanced Cancer
Led by Boehringer Ingelheim · Updated on 2026-05-14
69
Participants Needed
6
Research Sites
188 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study is open to adults with advanced cancer (solid tumours) for whom previous treatment was not successful, or no treatment exists. The study tests different doses of BI 3810944 to find out which doses they can tolerate. Another purpose is to identify the most suitable dose of BI 3810944 and to find out whether it helps people with advanced cancer. BI 3810944 may help fight cancer. Participants get BI 3810944 usually once every 3 weeks. At treatment start, it is given once a week for a short time. Participants may continue to get BI 3810944 as long as they benefit from treatment but no longer than 2 years. During this time, they regularly visit the study site. The first study visits include overnight stays at the hospital. At the visits, study doctors check participants' health, take necessary laboratory tests, and note any unwanted effects. The doctors also regularly check the size of the tumour with imaging methods.
CONDITIONS
Official Title
A Study of BI 3810944 in Patients With Advanced Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older
- Histologically or cytologically confirmed diagnosis of solid tumor or melanoma
- For Part A: Disease has not responded to conventional treatment or no effective therapy exists
- For Part B: Disease progressed on or is intolerant to standard therapies with no more than 3 previous lines of treatment (excluding adjuvant/neoadjuvant therapies and tumor-infiltrating lymphocyte treatments)
- Known B-raf protein kinase (BRAF) mutation status prior to screening for Part B
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- At least one measurable lesion outside the central nervous system (CNS) per RECIST v1.1
- Adequate organ function
- Life expectancy of at least 3 months at trial start
- All previous treatment-related toxicities resolved to CTCAE Grade 1 or less, except alopecia and peripheral neuropathy (Grade 2 or less) and amenorrhea/menstrual disorders (any grade)
You will not qualify if you...
- Active primary central nervous system malignancy or untreated CNS metastases or carcinomatous meningitis
- Recent brain radiotherapy or surgery less than 2 weeks before first dose (except if completed at least 2 weeks prior with stable conditions)
- Use of steroids or anti-epileptic drugs within 7 days before first dose except physiologic steroid doses and stable anti-epileptic dosing for CNS disease
- Diagnosis of immunodeficiency or receiving chronic systemic immunosuppressive therapy exceeding prednisone 10 mg daily or equivalent within 7 days before first dose
- Receipt of any other anticancer drug within 28 days or 5 half-lives prior to first dose
- Receipt of extensive field radiotherapy including whole brain irradiation within 2 weeks prior to first dose
- Prior organ transplant or hematopoietic stem-cell transplant
- Use of anticoagulant treatment that cannot be safely interrupted if needed
- Women who are pregnant, breastfeeding, or plan to become pregnant or breastfeed during the trial or within 4 months after last dose
AI-Screening
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Trial Site Locations
Total: 6 locations
1
University of Louisville
Louisville, Kentucky, United States, 40202
Not Yet Recruiting
2
Tennessee Oncology, PLLC - Elliston Place Plaza DDU
Nashville, Tennessee, United States, 37203
Actively Recruiting
3
University of Virginia Health System
Charlottesville, Virginia, United States, 22908
Not Yet Recruiting
4
Cliniques Universitaires Saint-Luc
Brussels, Belgium, 1200
Not Yet Recruiting
5
UZ Leuven
Leuven, Belgium, 3000
Not Yet Recruiting
6
Radboud Universitair Medisch Centrum
Nijmegen, Netherlands, 6525 GA
Not Yet Recruiting
Research Team
B
Boehringer Ingelheim
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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