Actively Recruiting
A First-in-human, Phase I, Open-label, Non-randomized, Multicentre Dose Escalation and Expansion Trial of BI 3810944 in Patients With Solid Tumours and Melanoma
Led by Boehringer Ingelheim · Updated on 2026-05-14
69
Participants Needed
6
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating BI 3810944, a drug being studied in adults with advanced solid tumors or melanoma when previous treatments have failed or no effective options are available. This phase 1 trial aims to find the doses of BI 3810944 that patients can tolerate and identify the most suitable dose for further study. The research also investigates whether BI 3810944 may help in fighting advanced cancer by monitoring participants' health and tumor response. Participants receive BI 3810944 usually once every three weeks, with an initial period where it is given once a week for a short time. They may continue treatment for up to two years as long as they benefit from it. The study is divided into two parts: Part A focuses on dose escalation to determine safety and tolerability, while Part B expands to evaluate the drug’s effects at the identified dose. During the study, participants regularly visit the site for health checks, laboratory tests, and monitoring of any side effects. Tumor size is assessed frequently using imaging methods. The primary outcomes include measuring dose-limiting toxicities and cytokine release syndrome in Part A and objective response in Part B, with ongoing safety and effectiveness evaluations. Participants’ involvement may last up to two years depending on treatment duration and response.
CONDITIONS
Brief 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
- Diagnosis of solid tumour or melanoma confirmed by histology or cytology
- For Part A: Disease progressed after conventional treatment or no proven therapy exists
- For Part B: Disease progressed on or intolerance to standard therapies with no more than 3 prior treatment lines
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- At least one measurable lesion outside the central nervous system
- Adequate organ function
- Life expectancy of at least 3 months as judged by investigator
- Resolved prior treatment toxicities to CTCAE Grade 1 or less (some exceptions apply)
You will not qualify if you...
- Active primary central nervous system (CNS) cancer or untreated CNS metastases
- Recent radiotherapy or surgery for brain metastases within 2 weeks
- Use of steroids above physiologic doses or immunosuppressive therapy within 7 days before first dose
- Anticancer therapy within 28 days or 5 half-lives before first dose
- Prior organ transplant or hematopoietic stem-cell transplant
- Anticoagulant treatment that cannot be safely interrupted
- Pregnant or breastfeeding women or those planning pregnancy during the trial or within 4 months after last dose of BI 3810944
- Other exclusion criteria as per study protocol 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 24 months
Participants receive the investigational drug BI 3810944 to treat their advanced cancer. The treatment includes dose escalation and dose expansion phases.
Visits occur regularly during the treatment period as per protocol
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
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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