Brigimadlin for Solid Cancers

No longer recruiting at 87 trial locations

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Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Boehringer Ingelheim

Must not be taking: MDM2-p53 antagonists

Disqualifiers: Active bleeding, Major surgery, others

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

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: Up to 30 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new medicine, BI 907828 (also known as Brigimadlin), to determine its effectiveness for people with certain types of advanced cancer, specifically in the bile ducts, pancreas, lungs, or bladder. BI 907828 blocks a protein (MDM2) that aids cancer cell growth. Participants will take a tablet every three weeks and visit the study site regularly to assess their cancer's response and monitor their health. The trial seeks individuals whose previous cancer treatments failed or who have no other treatment options. Candidates may qualify if they have one of these advanced cancers and have exhausted all standard treatments. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

Do I need to stop my current medications to join the trial?

The trial protocol does not specify if you need to stop your current medications. However, if you are taking any medications that might interfere with the trial, you may need to stop them. 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) is generally safe for most patients, with side effects that are not too severe. In one study, patients with biliary tract cancer had encouraging results, with some experiencing tumor shrinkage or stable disease. This suggests the treatment is effective without causing major issues.

Another study found that brigimadlin was safe for people with advanced solid tumors. Patients tolerated the treatment well and showed signs of the drug's effectiveness. Overall, brigimadlin appears to be well-tolerated by most people, making it a potentially safe option for those seeking new cancer treatments. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Brigimadlin (BI 907828) is unique because it targets the MDM2-p53 interaction, a novel approach in the fight against solid cancers. Most treatments for these cancers, like chemotherapy, broadly attack rapidly dividing cells, often causing significant side effects. Brigimadlin, however, specifically inhibits the MDM2 protein, which helps cancer cells avoid the self-destruct process. By reactivating the tumor-suppressing p53 pathway, it aims to selectively eliminate cancer cells while sparing healthy ones. Researchers are excited about this targeted mechanism because it could result in more effective treatments with fewer side effects.

What evidence suggests that BI 907828 might be an effective treatment for advanced cancer in the biliary tract, pancreas, lung, or bladder?

Research has shown that brigimadlin, also known as BI 907828, may help treat advanced solid tumors in the bile ducts, pancreas, lungs, and bladder. Participants in this trial will receive brigimadlin as part of the treatment arm. Studies have found that brigimadlin is generally safe and can shrink tumors in some patients. It blocks a protein that often aids cancer cell growth. Early results suggest it might be effective for patients who haven't responded to other treatments. Overall, the evidence supports its potential to help people with these types of cancers. ^{1 3 5 6 7}

Are You a Good Fit for This Trial?

Adults with advanced biliary tract, pancreatic, lung (adenocarcinoma), or bladder cancer who have tried all other treatments without success or for whom no treatment exists. Participants must have a specific genetic profile (MDM2 amplification and TP53 wild-type) in their tumors, be able to take oral medication every three weeks, and commit to regular health checks at the study site.

Inclusion Criteria

I have advanced lung adenocarcinoma and have tried all standard treatments.

My organs are working well.

I have advanced biliary tract cancer and cannot be treated with surgery or standard treatments.

Exclusion Criteria

I have no health issues that would stop me from following the trial or affect the drug's evaluation.

I have never taken brigimadlin or similar drugs targeting MDM2-p53 or MDMX-p53.

I am currently experiencing bleeding or have a high risk of bleeding.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants take BI 907828 as a tablet once every 3 weeks. Regular visits to the study site for health checks and monitoring of tumour size and spread.

Up to 30 months

Regular visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4-8 weeks

What Are the Treatments Tested in This Trial?

Interventions

• BI 907828

Trial Overview The trial is testing Brigimadlin (BI 907828), an MDM2 inhibitor taken as a tablet once every three weeks by patients with certain advanced cancers. The goal is to see if it can shrink tumors or stop them from spreading. Patients can continue taking the drug as long as they benefit from it and tolerate its effects.

How Is the Trial Designed?

Group I: brigimadlin (BI 907828) treatment arm Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Boehringer Ingelheim

Lead Sponsor

Trials

2,566

Recruited

16,150,000+

Citations

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

The MDM2–p53 Antagonist Brigimadlin (BI 907828) in ... These results demonstrate that brigimadlin has a manageable safety profile and shows encouraging signs of efficacy in patients with advanced/metastatic solid ...

2. ascopubs.org ascopubs.org/doi/10.1200/JCO.2024.42.3_suppl.487

Efficacy and safety of brigimadlin (BI 907828), an MDM2– ... 487. Background: Outcomes remain poor for pts treated with standard-of-care chemotherapy for advanced biliary tract cancer (BTC).

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

This Study Aims to Find the Best Dose of BI 907828 ... This Study Aims to Find the Best Dose of BI 907828 (Brigimadlin) in Patients With Different Types of Advanced Cancer (Solid Tumors). ClinicalTrials.gov ID ...

4. annalsofoncology.org annalsofoncology.org/article/S0923-7534(23)02696-0/fulltext

673P A phase I dose-escalation and expansion study ... BI 907828 demonstrated antitumour activity and a manageable safety profile in pts with advanced solid tumours, including those with BTC; dose expansion is ...

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 ... The safety and efficacy of brigimadlin are currently being assessed in advanced solid tumors in 2 phase 1a/1b dose-escalation/expansion trials, both as a ...

6. 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 ...

7. content.boehringer-ingelheim.com content.boehringer-ingelheim.com/DAM/8c1cd622-4d12-411b-85dc-b0f400d6b045/macarulla_1403.1%20.2%20btc%20update%20asco%20gi%20poster.pdf

Efficacy and safety of brigimadlin (BI 907828), an MDM2– ... • The safety and efficacy of brigimadlin in a range of advanced solid tumors is currently being assessed in two. Phase Ia/Ib dose-escalation ...