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MDM2 Inhibitor
BI 907828 + Ezabenlimab (+/- BI 754111) for Advanced Cancer
Phase 1
Recruiting
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights
Study 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.Check my eligibility
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.See study design
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.
Select...
I have an advanced cancer that can't be removed by surgery and can provide a sample of my tumor.
Select...
My cancer has worsened or returned after all standard treatments, or I can't receive them.
Select...
I am fully active or can carry out light work.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Phase Ia - maximum tolerated dose (MTD) of BI 907828 in combination with ezabenlimab based on the number of patients with dose limiting toxicities (DLTs) during the first treatment cycle
Phase Ib - Objective response (OR)
Phase Ib - Progression free survival
Secondary outcome measures
Phase Ia - AUC0-tz: Area under the concentration-time curve in plasma for BI 907828 and ezabenlimab over the time interval from 0 to the last quantifiable time point (during the first cycle)
Phase Ia - Cmax : Maximum measured plasma concentration of BI 907828 and ezabenlimab (during the first cycle)
Phase Ia - Number of patients with DLTs observed during the entire treatment period
+4 moreTrial 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
Find a Location
Who is running the clinical trial?
Boehringer IngelheimLead Sponsor
2,507 Previous Clinical Trials
11,340,767 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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are any new participants being added to this trial?
"As per the latest update from clinicaltrials.gov, this research is actively searching for human subjects to participate in their trial. It was initially advertised on June 11th 2019 and has since been updated November 15th 2022."
Answered by AI
Is BI 907828 likely to induce any adverse effects for individuals undergoing treatment?
"The available information on BI 907828's safety is limited, so the score assigned by Power was a 1. This reflects that this is an early-stage medical trial with minimal data indicating efficacy and safety."
Answered by AI
How many individuals are involved in this clinical investigation?
"This research project, funded by Boehringer Ingelheim, necessitates engaging 140 eligible patients across multiple locations including Yale Cancer Center in New Haven and Memorial Sloan-Kettering Cancer Center in Manhattan."
Answered by AI
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