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Study of BI 3810944 for Advanced Solid Tumors and Melanoma

This study is for adults with advanced solid tumors or melanoma where previous treatments haven't worked or aren't an option. It's testing a drug called BI 3810944. The main goals are to find a safe dose of BI 3810944 and see if it helps shrink tumors. You would receive BI 3810944, usually every three weeks, but weekly at the start. You might continue treatment for up to two years if it's helping. Regular visits to the study site are required, and initial visits include overnight hospital stays. The study aims to enroll 69 participants, but its current status is unclear.

Study design
This is an interventional study, meaning participants will receive a specific treatment. It aims to enroll 69 participants.
What's involved
You would receive BI 3810944, usually every 3 weeks, with weekly doses at the start. You may continue treatment for up to 2 years, with regular study site visits and initial overnight hospital stays.
Compensation
Not stated in the trial record.
Follow-up
Objective Response (tumor shrinkage) will be measured for up to 24 months.

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NCT07224425

A Study of BI 3810944 in Patients With Advanced Cancer

Recruiting
PHASE1Ages 18+InterventionalTreatment
Boehringer Ingelheim
~69 participants
Updated 2026-07-22 on ClinicalTrials.gov
What's tested:BI 3810944

At a glance

Recruiting sites
2 of 7 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Part A (dose escalation): Occurrence of Cytokine Release Syndrome (CRS) Grade 1 or 2 during the Maximum Tolerated Dose (MTD) evaluation period
Measured over approximately 2 months
+2 more outcomes measured

Conditions

Solid Tumours
Melanoma

Explore related trials

MelanomaSolid NeoplasmBRAF Gene

Where it's being run

7 sites across 6 states
Belgium2
Kentucky1
Tennessee1
Texas1
Virginia1
Netherlands1

Who to contact

Boehringer Ingelheim
[email protected]
1-800-243-0127
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Part A only: participants with any histologically or cytologically confirmed diagnosis of solid tumour who failed conventional treatment or for whom no therapy of proven efficacy exists or who is not eligible for established treatment options. Participant must have exhausted available treatment options known to prolong survival for their disease.
Part B only: participants with histologically or cytologically confirmed diagnosis of who has progressed on, or is intolerant to available standard therapies, or for whom no standard therapy with proven benefit exists according to the local and institutional guidelines. Participants should not have received \>3 previous lines of treatment (excluding prior systemic regimens received at adjuvant or neoadjuvant setting and excluding treatment with tumour-infiltrating lymphocytes at any timepoint). B-raf protein kinase (BRAF) mutation status must be known prior to screening 2. Eastern cooperative oncology group (ECOG) performance status of 0 or 1 3. Presence of at least one measurable lesion outside of central nervous system (CNS) as defined per response evaluation criteria in solid tumours (RECIST v 1.1) 4. Age ≥18 years 5. Adequate organ function 6. Life expectancy of ≥3 months at the start of the trial treatment in the opinion of the investigator

Exclusion

Participants with asymptomatic (i.e. no clinical neurological symptoms) brain lesions are eligible provided they meet the following criteria:
Radiotherapy or surgery for brain metastases was completed ≥2 weeks before the first administration of BI 3810944
Patient is off steroids for ≥7 days (physiologic doses of steroids are permitted), and the patient is off anti-epileptic drugs for ≥7 days or on stable doses of anti-epileptic drugs for malignant CNS disease 2. A diagnosis of immunodeficiency; receiving chronic systemic therapy exceeding prednisone 10 mg daily or equivalent or any other form of immunosuppressive therapy within 7 days before the first dose of BI 3810944 3. Prior anticancer therapy:
Participants who have been treated with any other anticancer drug(s), within 28 days or within 5 half-life periods (whichever is shorter) prior to the first administration of BI 3810944
Participants who have been treated with extensive field radiotherapy including whole brain irradiation, within 2 weeks prior to first administration of BI 3810944 4. Prior treatment with organ transplant or hematopoietic stem-cell transplant 5. Anticoagulant treatment that cannot be safely interrupted based on opinion of the investigator if medically needed (e.g. biopsy)

What this trial measures

  • Part A (dose escalation): Occurrence of Cytokine Release Syndrome (CRS) Grade 1 or 2 during the Maximum Tolerated Dose (MTD) evaluation periodapproximately 2 months
  • Part A (dose escalation): Occurrence of Dose Limiting Toxicity (DLTs) during the MTD evaluation periodapproximately 2 months
  • Part B (dose expansion): Objective Response (OR)up to 24 months

    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