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MDM2 Inhibitor
BI 907828 + Ezabenlimab (+/- BI 754111) 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
ECOG performance status of 0 or 1.
Phase Ia (dose escalation part): Patients with confirmed diagnosis of unresectable, advanced and/or metastatic solid tumors (any type) irrespective of TP53 mutation status, with either evaluable or non-evaluable disease, and availability and willingness to provide a sample of archival FFPE tumor tissue material
Must not have
Any other documented active or suspected malignancy or history of malignancy within 3 years prior to screening
Active bleeding, significant risk of haemorrhage, or current bleeding disorder
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing a combination of two drugs to see if it can help people with advanced cancer.
Who is the study for?
Adults with various advanced cancers, including specific soft tissue sarcomas and lung, stomach, bladder or bile duct cancers. Participants must be over 18, have acceptable blood counts and organ function, not be pregnant or nursing, use reliable birth control if applicable, and cannot have other active malignancies or severe health conditions that could affect trial participation.
What is being tested?
The study tests different doses of BI 907828 combined with ezabenlimab in patients with advanced cancer. The first part determines the highest tolerable dose; the second part assesses tumor shrinkage using this dose combination. Treatment includes infusions of ezabenlimab every three weeks alongside oral BI 907828 tablets.
What are the potential side effects?
Potential side effects include immune system reactions leading to inflammation in organs (like pneumonitis), infusion-related reactions such as fever or chills, fatigue from treatment burden on the body's energy resources, digestive issues like nausea or diarrhea due to medication effects on gastrointestinal tract.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am fully active or can carry out light work.
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I have an advanced cancer that can't be removed by surgery and can provide a sample of my tumor.
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My cancer has worsened or returned after all standard treatments, or I can't receive them.
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I am fully active or can carry out light work.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have not had any other cancer in the last 3 years.
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I am currently experiencing bleeding or have a high risk of bleeding.
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I have an autoimmune disease that needs treatment.
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I have never taken BI 907828 or similar drugs targeting MDM2-p53 or MDMX-p53.
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I do not have an active infection needing treatment when starting this trial.
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I have brain metastases that are causing symptoms.
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I have been diagnosed with HIV.
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I haven't had major surgery in the last 3 months and don't plan any in the next year.
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I haven't taken high doses of steroids like prednisone (more than 10 mg daily) in the last 4 weeks.
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I am not pregnant, nursing, or planning to become pregnant during the trial.
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
4Treatment groups
Experimental Treatment
Group I: Dose Expansion - Cohort 2 - BI 907828 + ezabenlimabExperimental Treatment2 Interventions
Group II: Dose Expansion - Cohort 1 BI 907828 + ezabenlimabExperimental Treatment2 Interventions
Group III: Dose Escalation - BI 907828 + ezabenlimab + BI 754111Experimental Treatment3 Interventions
All neoplasms
Group IV: Dose Escalation - BI 907828 + ezabenlimabExperimental Treatment2 Interventions
All neoplasms
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
BI 754111
2018
Completed Phase 1
~320
ezabenlimab
2018
Completed Phase 1
~260
Find a Location
Who is running the clinical trial?
Boehringer IngelheimLead Sponsor
2,549 Previous Clinical Trials
15,768,941 Total Patients Enrolled
3 Trials studying Tumors
1,624 Patients Enrolled for Tumors
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I still have side effects from my last treatment.I am 18 years old or older.I am using two reliable birth control methods if I can have children.I am fully active or can carry out light work.I had anti-PD-1/PD-L1 treatment, but my last dose was over 28 days ago.I have not had any other cancer in the last 3 years.I belong to a specific group based on my cancer type and past treatments.I am currently experiencing bleeding or have a high risk of bleeding.You need to have a certain level of white blood cells called neutrophils, which help fight infections, in your body.I am 18 years old or older.Your doctor thinks that you will live for at least 12 more weeks after starting the treatment.Your platelet count should be at least 100 billion per liter.You must give your written permission (signed and dated) before any study procedures, tests or samples can be taken.I have an advanced cancer that can't be removed by surgery and can provide a sample of my tumor.My cancer has MDM2 amplification and normal TP53, with a measurable lesion.I have an autoimmune disease that needs treatment.My cancer has worsened or returned after all standard treatments, or I can't receive them.The doctor thinks you will live for at least 12 more weeks after starting the treatment.I have never taken BI 907828 or similar drugs targeting MDM2-p53 or MDMX-p53.I am willing to give blood samples for research purposes.I am fully active or can carry out light work.I do not have an active infection needing treatment when starting this trial.My heart's electrical activity and pumping ability are within normal ranges.My tumor has a specific mutation in the TP53 gene.I have brain metastases that are causing symptoms.You have a history of long-term alcohol or drug abuse.You are allergic to the trial drugs or any substances used to make them.I do not have any serious illness that would prevent me from following the trial's requirements.I last received anti-PD-1/PD-L1 therapy over 28 days ago.My blood, liver, kidney, and clotting tests are normal.My cancer has worsened despite treatment, or I can't receive standard treatments.I have been diagnosed with HIV.I haven't had major surgery in the last 3 months and don't plan any in the next year.I haven't taken high doses of steroids like prednisone (more than 10 mg daily) in the last 4 weeks.I am not pregnant, nursing, or planning to become pregnant during the trial.I am willing to give blood samples for the study's tests.My blood counts are within normal ranges.I have a measurable tumor and my cancer does not have TP53 mutations.I have not had lung inflammation or disease in the last 5 years.
Research Study Groups:
This trial has the following groups:- Group 1: Dose Escalation - BI 907828 + ezabenlimab
- Group 2: Dose Expansion - Cohort 1 BI 907828 + ezabenlimab
- Group 3: Dose Expansion - Cohort 2 - BI 907828 + ezabenlimab
- Group 4: Dose Escalation - BI 907828 + ezabenlimab + BI 754111
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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