A Phase 1 interventional study of BI 3810944 in Solid Tumours and Melanoma, sponsored by Boehringer Ingelheim. Recruiting at 7 sites in 3 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-29.
Sponsored by Boehringer Ingelheim · Phase 1, Interventional, and Treatment
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.
Trial participant population specifically to Part A and B:
Exclusion Criteria:
Active primary central nervous system (CNS) malignancy, active untreated CNS metastases and/or carcinomatous meningitis
Participants with asymptomatic (i.e. no clinical neurological symptoms) brain lesions are eligible provided they meet the following criteria:
Prior anticancer therapy:
Drug: BI 3810944
Drug: BI 3810944
BI 3810944
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
Part A (dose escalation): Occurrence of Dose Limiting Toxicity (DLTs) during the MTD evaluation period
Time frame: approximately 2 months
Part B (dose expansion): Objective Response (OR)
OR, defined as best overall response of confirmed CR and/or confirmed PR, where best overall response is determined according to RECIST v 1.1 assessed from first treatment administration until the earliest event of PD, death or last evaluable tumour assessment before start of subsequent anticancer therapy, loss to follow up or withdrawal of consent
Time frame: up to 24 months
Part A (dose escalation): Occurrence of DLTs during the on-treatment period
Time frame: approximately 2 months
Part A (dose escalation): Occurrence of Adverse Event (AEs) during the on-treatment period
Time frame: approximately 2 months
Part B (dose expansion): Occurrence of AEs during the on-treatment period
Time frame: up to 24 months
Part B (dose expansion): Duration of Response (DoR)
DoR, defined as the time from first documented Complete Response (CR) or Partial Response (PR) until the earliest of Progressive Disease (PD) or death among trial participants with OR according to RECIST v 1.1
Time frame: up to 24 months
Part B (dose expansion): Disease control (DC)
DC, defined as best overall response of confirmed CR, or confirmed PR, or Stable Disease (SD) where best overall response is defined according to RECIST v 1.1 from first treatment administration until the earliest of PD, death or last evaluable tumour assessment before start of subsequent anticancer therapy, loss to follow-up or withdrawal of consent
Time frame: up to 24 months
Part B (dose expansion): Progression-free survival (PFS)
PFS, defined as the time from first administration until tumour progression according to RECIST v 1.1 or death from any cause, whichever occurs earlier
Time frame: up to 24 months
Parts A and B (dose escalation and dose expansion): Maximum measured concentration of BI 3810944 in serum (Cmax)
Time frame: up to 24 months
Parts A and B (dose escalation and dose expansion): Area under the serum concentration-time curve over the time interval from 0 to the last measured time point, tz (AUC0-tz)
Time frame: up to 24 months
Parts A and B (dose escalation and dose expansion): Terminal half-life of BI 3810944 (t1/2)
Time frame: up to 24 months
Plan to share: No — Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents. Exceptions might apply, e.g. studies in products where Boehringer Ingelheim is not the license holder; studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; studies conducted in a single center or targeting rare diseases (in case of low number of patients and therefore limitations with anonymization). For more details refer to: https://www.clinicalstudies.boehringer-ingelheim.com/msw/datasharing
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Boehringer Ingelheim