BI 907828 for Advanced Cancer

No longer recruiting at 36 trial locations

Overseen By Additional US locations available on demand. Please contact for options.

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Boehringer Ingelheim

Must not be taking: MDM2-p53 antagonists

Disqualifiers: TP53 mutant tumor, Brain metastases, others

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

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called brigimadlin (BI 907828) for individuals with advanced cancer (solid tumors). The main goal is to determine the safest dose patients can tolerate and assess its effectiveness in shrinking tumors. Participants will take brigimadlin as a tablet, either on one day every three weeks or on two days every four weeks. This trial targets adults with cancer that has worsened or returned, who cannot receive standard treatments, or have specific types of cancer known as MDM2 amplified sarcomas. Regular health check-ups will monitor the treatment's effects. As a Phase 1 trial, this research aims to understand how brigimadlin works in people, offering participants the opportunity to be among the first to receive this new treatment.

Do I have to stop taking my current medications for the trial?

The trial protocol does not specify if you must stop taking your current medications, but it mentions that patients who need to continue restricted medications or drugs that might interfere with the trial cannot participate. It's best to discuss your specific medications with the trial team.

Is there any evidence suggesting that BI 907828 is likely to be safe for humans?

Research has shown that brigimadlin (BI 907828) has a manageable safety profile based on previous studies. It was tested on patients with advanced biliary tract cancer, and the results were promising. Participants generally tolerated the treatment well, with only mild to moderate side effects reported. Common side effects included tiredness and nausea, but these were usually not severe.

This study aims to find the optimal dose that people can handle without too many side effects. As an early study, the focus is on determining how much of the treatment is safe for people to take. Doctors will regularly monitor participants' health to ensure the treatment remains safe. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about BI 907828 because it offers a fresh approach to tackling advanced cancer. Unlike traditional treatments that often target cancer cells broadly, BI 907828 works by specifically inhibiting a protein called MDM2. This protein is known to interact with and suppress the activity of p53, a critical protein for controlling cell growth and preventing tumor formation. By targeting MDM2, BI 907828 aims to restore the natural cancer-fighting abilities of p53, potentially leading to better outcomes for patients with fewer side effects.

What evidence suggests that BI 907828 might be an effective treatment for advanced cancer?

Research has shown that brigimadlin (BI 907828), the investigational treatment in this trial, targets a protein called MDM2, which contributes to cancer cell growth. In early studies, brigimadlin produced promising results, with 11.1% of patients experiencing tumor shrinkage. It also controlled the disease in 74.1% of patients by halting tumor growth. These results were particularly encouraging for patients with certain types of well-differentiated tumors. Overall, brigimadlin appears to be a potential new cancer treatment, but further research is needed to confirm these findings. ^{1 3 6 7 8}

Are You a Good Fit for This Trial?

Adults with various advanced solid tumors who have progressed after prior treatments or have no standard treatment options can join. They must be willing to provide tissue samples and undergo regular health checks. Those with specific genetic tumor profiles (TP53 wild type, MDM2-amplified) are eligible for certain study phases.

Inclusion Criteria

At least one target lesion that can be accurately measured per RECIST v.1.1

No standard treatments are suitable or available for my condition.

I have NSCLC, urothelial, gastric, biliary tract, or pancreatic cancer with specific genetic features and have received at least one treatment for advanced disease.

Exclusion Criteria

I have a history of unusual bleeding or clotting.

I have not taken BI 907828 or similar drugs targeting MDM2-p53 or MDMX-p53.

My tumor has a TP53 mutation.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation

Participants receive escalating doses of brigimadlin to determine the most suitable dose

Varies

Regular health checks

Dose Expansion

Participants receive the most suitable dose of brigimadlin to assess tumor response

Varies

Regular health checks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• BI 907828

Trial Overview The trial is testing the safety and effectiveness of a new cancer drug called BI 907828 (brigimadlin), an MDM2 inhibitor taken as a tablet. It aims to determine the best dose that shrinks tumors, given either once every three weeks or twice every four weeks.

How Is the Trial Designed?

Group I: Dose Expansion Experimental Treatment 1 Intervention

Group II: 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. ascopubs.org ascopubs.org/doi/10.1200/JCO.2024.42.3_suppl.487

Efficacy and safety of brigimadlin (BI 907828), an MDM2– ... Background: Outcomes remain poor for pts treated with standard-of-care chemotherapy for advanced biliary tract cancer (BTC).

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37269344/

The MDM2-p53 Antagonist Brigimadlin (BI 907828) in Patients ... We report phase Ia data indicating that the oral MDM2-p53 antagonist brigimadlin has a manageable safety profile and shows encouraging signs ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT03449381

This Study Aims to Find the Best Dose of BI 907828 ... The purpose of this study is to find out the most suitable dose of BI 907828 (brigimadlin) the participants can tolerate. The most suitable dose is used in the ...

4. aacrjournals.org aacrjournals.org/cancerdiscovery/article/13/8/1802/728135/The-MDM2-p53-Antagonist-Brigimadlin-BI-907828-in

The MDM2–p53 Antagonist Brigimadlin (BI 907828) in ... Preliminary efficacy was encouraging (11.1% overall response and 74.1% disease control rates), particularly in patients with well-differentiated or ...

5. ccanewsonline.com ccanewsonline.com/issues/2024/march-2024-vol-5-no-1/efficacy-and-safety-of-brigimadlin-bi-907828-in-patients-with-advanced-btc-data-from-2-phase-1a-1b-dose-escalation-expansion-trials

Efficacy and Safety of Brigimadlin (BI 907828) in Patients ... A study of patients with advanced biliary tract cancer found that adding lenvatinib to durvalumab and gemcitabine-based chemotherapy improved progression-free ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38567193/

Efficacy and Safety of the MDM2-p53 Antagonist ... Brigimadlin demonstrated anti-tumor activity in patients with advanced MDM2-amplified BTC, and warrants further investigation.

7. ascopubs.org ascopubs.org/doi/10.1200/JCO.2023.41.4_suppl.543

Efficacy and safety of the MDM2–p53 antagonist BI 907828 ... The MDM2–p53 antagonist BI 907828 has shown a manageable safety profile and encouraging preliminary efficacy in patients with BTC, with 5 PRs and 2 SD in 8 ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10401071/

The MDM2–p53 Antagonist Brigimadlin (BI 907828) in ... We report phase Ia data indicating that the oral MDM2–p53 antagonist brigimadlin has a manageable safety profile and shows encouraging signs of efficacy in ...