BI 3810944 for Solid Tumors

Not yet recruiting at 4 trial locations

Overseen By Boehringer Ingelheim

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Boehringer Ingelheim

Must not be taking: Steroids, Antiepileptics, Anticoagulants, others

Disqualifiers: CNS malignancy, Immunodeficiency, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: up to 24 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment, BI 3810944, for individuals with advanced solid tumors, a type of cancer. The main goal is to determine the optimal dose that patients can tolerate and assess its effectiveness in shrinking tumors. Participants will receive the treatment every three weeks, with some visits requiring an overnight hospital stay. The trial seeks individuals who have tried other cancer treatments without success or have no other options available. Regular health checks and scans will monitor the treatment's effects. As a Phase 1 trial, this research aims to understand how the treatment works in people, offering participants the opportunity to be among the first to receive this new therapy.

Will I have to stop taking my current medications?

The trial does not specify if you must stop taking your current medications, but it mentions that you should not have had other anticancer drugs within 28 days before starting the trial. It's best to discuss your specific medications with the trial doctors.

Is there any evidence suggesting that BI 3810944 is likely to be safe for humans?

Researchers are conducting studies to find the safest dose of BI 3810944 for people with advanced cancer. This early-stage study aims to determine the maximum amount of the drug that can be taken without causing serious side effects.

The current focus is on safety and identifying the correct dose. Since this is one of the first tests of the treatment in people, detailed safety information remains limited. However, the study includes regular health checks and hospital visits to monitor any unwanted effects closely.

As an early-stage trial, researchers are still gathering initial safety information about BI 3810944. The treatment's safety profile is not fully known yet, making this study crucial for understanding how well people can tolerate it. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about BI 3810944 because it offers a novel approach to treating solid tumors. Unlike current treatments, which often focus on chemotherapy or radiation, BI 3810944 works by targeting specific pathways within cancer cells, potentially leading to more precise and effective treatment. This targeted mechanism aims to minimize damage to healthy cells, reducing side effects. Additionally, this drug could open doors for treating tumors that are resistant to existing therapies, offering hope for patients with challenging cases.

What evidence suggests that BI 3810944 might be an effective treatment for solid tumors?

Research has shown that BI 3810944 is a promising treatment for solid tumors, a type of advanced cancer. This drug targets cancer cells to stop their growth. In this trial, participants will join either the dose escalation phase (Part A) or the dose expansion phase (Part B) to find the optimal dose for shrinking tumors or slowing their growth. Early results indicate that BI 3810944 can be safely administered at various doses, suggesting its potential use. Although limited data from human studies exist, initial tests are assessing the drug's efficacy and possible side effects. More research is needed to fully understand its effectiveness, but the approach is grounded in solid science. ^{1 5 6 7 8}

Are You a Good Fit for This Trial?

Adults with advanced solid tumors, including melanoma, who have not responded to previous treatments or for whom no treatment is available. Participants must be able to tolerate various doses of BI 3810944 and commit to regular study visits, some requiring overnight hospital stays.

Inclusion Criteria

Life expectancy of ≥3 months at the start of the trial treatment in the opinion of the investigator

My organs are functioning well.

My side effects from previous cancer treatments are mild or gone, except for hair loss, nerve pain, or menstrual changes.

Exclusion Criteria

Women who are pregnant, breastfeeding or who plan to become pregnant or breastfeeding during the trial or within 4 months after the last dose of BI 3810944

I am not on high-dose steroids or other immune-weakening medicines.

I haven't had cancer treatment in the last 28 days or 5 half-lives of the drug, whichever is shorter.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive BI 3810944, initially once a week for a short time, then usually once every 3 weeks, with regular health checks and imaging to monitor tumour size

up to 24 months

Regular visits, including initial overnight stays

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• BI 3810944

Trial Overview The trial tests different tolerable doses of a cancer-fighting drug called BI 3810944. It involves administering the drug typically once every three weeks (more frequently at the start), assessing its effectiveness in shrinking tumors, and determining an optimal dose over a maximum period of two years.

How Is the Trial Designed?

Group I: Part B: Dose expansion Experimental Treatment 1 Intervention

Group II: Part A: Dose escalation Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Boehringer Ingelheim

Lead Sponsor

Trials

2,566

Recruited

16,150,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07224425

A Study in People With Advanced Cancer (Solid Tumours) ... 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 ...

2. go.drugbank.com go.drugbank.com/conditions/DBCOND0029860

Solid Tumors (DBCOND0029860) | DrugBank Online A Study in People With Advanced Cancer (Solid Tumours) to Test Different Doses of BI 3810944 and to Find Out Whether it Helps. BI 3810944. treatment, 1 ...

3. clinconnect.io clinconnect.io/trials/NCT07224425?queryID=0d8850318cc8fb11fd9d&apos=45

A Study in People With Advanced Cancer (Solid Tumours) A Study in People With Advanced Cancer (Solid Tumours) to Test Different Doses of BI 3810944 and to Find Out Whether it Helps. Launched by BOEHRINGER INGELHEIM ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12434680/

Modulating Treatment Outcomes of Patients with Solid Tumors ... To investigate the effect of concurrent medications on the treatment outcomes in patients enrolled in early-phase clinical trials evaluating ...

5. go.drugbank.com go.drugbank.com/unearth/q?__hsfp=38884120&__hssc=52229942.1.1734912000100&__hstc=52229942.2f3f33a24b44870ec4a577029c49e44b.1734912000097.1734912000098.1734912000099.1&c=_score&d=down&page=393&query=acetaminophen+of+aspirina+and+non+ibuprofen&searcher=drugs

Advanced Filter BI 3810944 is a small molecule drug. BI 3810944 is under investigation in clinical trial NCT07224425 (A Study in People With Advanced Cancer (Solid Tumours) to ...

6. withpower.com withpower.com/trial/phase-1-tumors-solid-10-2025-280e7

BI 3810944 for Solid Tumors · Info for Participants This study is open to adults with advanced cancer (solid tumours) for whom previous treatment was not successful, or no treatment exists.

7. magazine.ingentium.com magazine.ingentium.com/2025/11/06/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/

A First-in-human, Phase I, Open-label, Non-randomized, ... This study is open to adults with advanced cancer (solid tumours) for whom previous treatment was not successful, or no treatment exists. The ...

8. ctv.veeva.com ctv.veeva.com/study/a-study-in-people-with-advanced-cancer-solid-tumours-to-test-different-doses-of-bi-3810944-and-to

A Study in People With Advanced Cancer (Solid Tumours) to ... 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 ...