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MDM2 Inhibitor

Brigimadlin for Solid Cancers

Phase 2
Recruiting
Research Sponsored by Boehringer Ingelheim
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Cohort 3 (lung adenocarcinoma): Locally advanced or metastatic lung adenocarcinoma. Patients must have unresectable disease and have received all available conventional therapies known to confer clinical benefit for their disease based on local approved standards.
Diagnosis of a solid tumour meeting the criteria for an open trial cohort
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 50 months
Awards & highlights

Study Summary

This trial is for adults with advanced cancer in the biliary tract, pancreas, lung, or bladder. It examines whether a medicine called BI 907828 can help when other treatments have been unsuccessful. Participants take the medicine regularly and are monitored for changes in their health.

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
While not explicitly listed in the provided information, side effects of MDM2 inhibitors like Brigimadlin may include nausea, vomiting, diarrhea, fatigue, blood count changes that could increase infection risk or cause bruising/bleeding easily. Regular monitoring will help identify any unwanted effects.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have advanced lung adenocarcinoma and have tried all standard treatments.
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My solid tumor qualifies for a specific trial group.
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My cancer has MDM2 amplification and normal TP53 according to tests.
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I can provide tissue samples for cancer gene testing.
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I am fully active or can carry out light work.
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All side effects from my previous cancer treatments are mild.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 50 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 50 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Objective response (OR)
Secondary outcome measures
Change from baseline in EORTC QLQ-BIL21 tiredness domain score
Change from baseline in EORTC QLQ-C30 fatigue domain score
Change from baseline in EORTC QLQ-C30 role functioning domain score
+7 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: brigimadlin (BI 907828) treatment armExperimental Treatment1 Intervention

Find a Location

Who is running the clinical trial?

Boehringer IngelheimLead Sponsor
2,507 Previous Clinical Trials
11,340,752 Total Patients Enrolled

Media Library

BI 907828 (MDM2 Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05512377 — Phase 2
Lung Cancer Research Study Groups: brigimadlin (BI 907828) treatment arm
Lung Cancer Clinical Trial 2023: BI 907828 Highlights & Side Effects. Trial Name: NCT05512377 — Phase 2
BI 907828 (MDM2 Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05512377 — Phase 2
Lung Cancer Patient Testimony for trial: Trial Name: NCT05512377 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many individuals are currently enrolled in this experiment?

"Affirmative. According to information provided on clinicaltrials.gov, the medical trial is actively seeking qualified candidates and was initially posted in late November 2022 before its most recent update occurring on March 6th 2023. 130 participants must be sourced from a total of 18 sites for this study."

Answered by AI

Is this research endeavor available for enrollment currently?

"Clinicaltrials.gov reveals that this clinical trial is still recruiting participants; it was initially posted on November 25th 2022 and underwent its latest revision on March 6th 2023."

Answered by AI

Has the BI 907828 treatment arm obtained clearance from the FDA?

"Due to the lack of efficacy data, BI 907828's safety is estimated at a rating of 2. Although it has been through Phase 2 trials and there are some results indicating its security."

Answered by AI

How many venues are providing data for this research?

"Presently, this research is occurring in 18 centres situated across Washington, Hat Yai and Bangkok. It is prudent for potential participants to select the closest location possible so as to reduce their travel costs should they choose to enroll."

Answered by AI

Who else is applying?

What state do they live in?
Colorado
Kentucky
What site did they apply to?
Hospital Vall d'Hebron
Johns Hopkins Sidney Kimmel Cancer Center at Sibley Memorial Hospital
Rocky Mountain Cancer Centers
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
0

Why did patients apply to this trial?

I'm willing to do anything to prolong my life.
PatientReceived 2+ prior treatments
Recent research and studies
clinicaltrials.govStudy
Brightline-2: A Study to Test Whether Brigimadlin (BI 907828) Helps People With Cancer in the Biliary Tract, Pancreas, Lung or Bladder
2022. "Brightline-2: A Study to Test Whether Brigimadlin (BI 907828) Helps People With Cancer in the Biliary Tract, Pancreas, Lung or Bladder". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05512377.
All > Metastatic Lung Cancer > Lung Cancer
~54 spots leftby Feb 2025
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