Brigimadlin for Cancer

Recruiting at 71 trial locations

Overseen By Boehringer Ingelheim

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Boehringer Ingelheim

Must be taking: Brigimadlin

Must not be taking: Restricted medications

Disqualifiers: Pregnancy, Disease progression, 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: 3

Duration: As long as participants benefit and can tolerate the treatment

90 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to assess how well patients with solid tumors tolerate long-term treatment with brigimadlin, a new cancer drug. Participants take brigimadlin tablets at the study site every three weeks, while doctors monitor their health and check the tumor's status during visits. This trial suits those who have received brigimadlin in a previous study and continue to benefit without severe side effects. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to important findings.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it mentions that participants should not receive restricted medications or any drug that might interfere with the trial. It's best to discuss your current medications with the trial team to see if they are allowed.

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

Research has shown that brigimadlin is generally safe for patients with various types of cancer. Studies involving patients with advanced or spreading solid tumors indicate that this treatment is usually well-tolerated. Most side effects can be managed, and the treatment has shown promise in slowing tumor growth.

In earlier studies, common side effects included anemia (a low count of red blood cells) and other manageable conditions. These side effects were usually more severe but not common for most patients. Overall, brigimadlin remains under study due to its potential benefits and the manageable nature of its side effects. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Brigimadlin is unique because it's designed to target cancer cells by reactivating the p53 protein, a crucial tumor suppressor that is often inactivated in various cancers. Most current treatments for cancer, such as chemotherapy and radiation, focus on killing rapidly dividing cells but can also harm healthy cells. Brigimadlin aims to specifically restore the function of p53 in cancer cells, potentially leading to more precise and less toxic treatment options. Researchers are excited about this treatment as it offers a new mechanism of action that could improve outcomes for patients with cancers resistant to traditional therapies.

What evidence suggests that brigimadlin might be an effective treatment for cancer?

Research has shown that brigimadlin, the treatment under study in this trial, may help shrink tumors and control cancer. In one study, a patient’s tumor size was reduced by nearly 49%. Another study found that 11.1% of patients responded well, with significant tumor shrinkage. Additionally, 74.1% of patients maintained disease control, preventing it from worsening. Brigimadlin blocks a protein called MDM2, which helps stop cancer cells from growing. These findings suggest brigimadlin could be effective for certain types of cancer. ^{1 2 3 6 7}

Are You a Good Fit for This Trial?

Adults with solid tumors who were in a previous brigimadlin study can join. They must be able to continue treatment, have signed consent, use effective birth control, and follow the trial's procedures. Their organs must work well and any past treatment side effects should be mild.

Inclusion Criteria

I am currently on brigimadlin or eligible to switch to it in a Boehringer Ingelheim trial.

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

Provision of signed and dated, written informed consent form (ICF) in accordance with International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use - Good Clinical Practice (ICH-GCP) and local legislation prior to any trial-specific procedures, sampling, or analyses

Exclusion Criteria

I am not pregnant, nursing, nor planning to become pregnant during the trial, and agree to stop breastfeeding.

My condition worsened or I had severe side effects on brigimadlin.

Patient who has already required 2 dose reductions and would require a third dose reduction at trial entry, unless the investigator deems treatment continuation beneficial, and the third dose reduction is agreed between the investigator and the sponsor

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants take brigimadlin as tablets once every 3 weeks at the study site. Health checks and monitoring for adverse effects are conducted.

As long as participants benefit and can tolerate the treatment

Every 3 weeks (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Open-label extension

Participants continue long-term treatment with brigimadlin as long as they benefit and can tolerate it

Up to 9 years

What Are the Treatments Tested in This Trial?

Interventions

• Brigimadlin

Trial Overview The trial tests long-term tolerance of brigimadlin in cancer patients from prior studies. It involves different cohorts based on previous exposure to brigimadlin or a comparator drug, with all now taking brigimadlin tablets every three weeks.

How Is the Trial Designed?

Group I: Brigimadlin 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/PMC10986405/

Efficacy and Safety of the MDM2–p53 Antagonist Brigimadlin ... The patient achieved SD on Day 36, and PR up to Day 162 (Figure 2E). The maximum tumor shrinkage was −49%. The patient was on treatment for 4.2 ...

2. 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).

3. 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 ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S1556086424014916

P3.12C.03 Efficacy and Safety of Brigimadlin, a MDM2-p53 ... In 3 patients treated in the Phase IIa/IIb monotherapy trial, having received 2 prior lines of conventional treatment, all achieved PR (tumor shrinkage 48%, 49% ...

5. esmoopen.com esmoopen.com/article/S2059-7029(24)00214-X/fulltext

56O A phase Ia/Ib study of the MDM2-p53 antagonist ... Conclusions. Brigimadlin q3w demonstrated manageable toxicity and encouraging efficacy with a high rate of disease control in DDLPS pts.

6. jto.org jto.org/article/S1556-0864(24)01491-6/fulltext

P3.12C.03 Efficacy and Safety of Brigimadlin, a MDM2-p53 ... Brigimadlin treatment was associated with encouraging preliminary efficacy in patients with advanced MDM2-amplified LUAD and a manageable safety profile.

7. pro.boehringer-ingelheim.com pro.boehringer-ingelheim.com/us/inoncology/our-pipeline/mdm2-p53-antagonist/brigimadlin-results

Brigimadlin-Results | InOncology Brigimadlin plus ezabenlimab showed a manageable safety profile, including in patients with liposarcoma · Most common any-cause grade ≥3 AEs were anemia (n=7), ...