A Study of BI 3810944 in Patients With Advanced Cancer

Part of paid clinical trials in Louisville, Kentucky.

Sponsor
Boehringer Ingelheim
Study ID
NCT07224425
Phase
PHASE1
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • BI 3810944 — DRUG
    BI 3810944

Study Details

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.

Key Dates

Start date
Feb 24, 2026
Status verified
May 2026
Primary completion
Oct 5, 2029
Completion
Oct 5, 2029

Study Design

Enrollment
69 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Part A: Dose escalation
  • Experimental: Part B: Dose expansion

Primary Outcome Measure

Part A (dose escalation): Occurrence of Cytokine Release Syndrome (CRS) Grade 1 or 2 during the Maximum Tolerated Dose (MTD) evaluation period [ Time Frame: approximately 2 months ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
University of LouisvilleLouisvilleKentucky40202
Boehringer Ingelheim
[email protected]
833-602-2368
Tennessee Oncology, PLLC - Elliston Place Plaza DDUNashvilleTennessee37203
Boehringer Ingelheim
[email protected]
833-602-2368
University of Virginia Health SystemCharlottesvilleVirginia22908
Boehringer Ingelheim
[email protected]
833-602-2368

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