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MDM2 Inhibitor
BI 907828 for Advanced Cancer
Phase 1
Waitlist Available
Research Sponsored by Boehringer Ingelheim
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients who are not eligible to receive standard of care treatments, and for whom no proven treatments exist
Patient has a tumor with either a known TP53 wild type status, or unknown TP53 status, and regardless of MDM2 amplification status, at the time of study entry
Must not have
Symptomatic metastases from non-brain tumors
Patients with history of bleeding diathesis
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing a new cancer drug, BI 907828, to see if it's effective and safe. Participants will take BI 907828 either once every three weeks or twice every four weeks, depending on how well they tolerate the drug. The goal is to see if BI 907828 causes tumors to shrink.
Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
As this is the first time brigimadlin is given to humans, side effects are not yet fully known but may include typical reactions related to cancer medications such as nausea, fatigue, blood count changes, and potential organ-specific toxicity.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
No standard treatments are suitable or available for my condition.
Select...
My tumor is either TP53 wild type or its TP53 status is unknown.
Select...
My sarcoma is TP53 wild type and MDM2-amplified, and it has spread.
Select...
My cancer is confirmed and has spread from where it started.
Select...
My cancer has grown or returned after treatment.
Select...
I am willing to have a tumor biopsy and blood tests for study purposes.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have symptoms from cancer spread not in my brain.
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I have a history of unusual bleeding or clotting.
Select...
I have not taken BI 907828 or similar drugs targeting MDM2-p53 or MDMX-p53.
Select...
My tumor has a TP53 mutation.
Select...
I haven't had major surgery in the last 3 months and don't plan any in the next year.
Select...
I need to keep taking certain medications that may affect the trial's safety.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Group I: Dose ExpansionExperimental Treatment1 Intervention
Group II: Dose EscalationExperimental Treatment1 Intervention
Find a Location
Who is running the clinical trial?
Boehringer IngelheimLead Sponsor
2,550 Previous Clinical Trials
15,769,016 Total Patients Enrolled
3 Trials studying Tumors
1,624 Patients Enrolled for Tumors
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Eligibility Criteria:
This trial includes the following eligibility criteria:- 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.My cancer can be measured by tests or seen on scans.I am willing to have blood tests for research purposes.I have a history of unusual bleeding or clotting.I am willing to have a tumor biopsy and blood tests for study purposes.I am willing to provide a new tumor sample after my cancer has worsened.I have not taken BI 907828 or similar drugs targeting MDM2-p53 or MDMX-p53.My tumor has a TP53 mutation.I haven't had major surgery in the last 3 months and don't plan any in the next year.I haven't had any cancer except for certain skin cancers or cervical cancer in the last 3 years.My sarcoma is MDM2 amplified and I need first line treatment.I have MDM2 amplified sarcoma and meet one of the previous criteria.My tumor is either TP53 wild type or its TP53 status is unknown.My sarcoma is TP53 wild type and MDM2-amplified, and it has spread.My cancer is confirmed and has spread from where it started.My cancer has grown or returned after treatment.I have symptoms from cancer spread not in my brain.I need to keep taking certain medications that may affect the trial's safety.
Research Study Groups:
This trial has the following groups:- Group 1: Dose Expansion
- Group 2: Dose Escalation
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