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Monoclonal Antibodies
BI 765179 + Ezabenlimab 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
Patients with locally advanced, unresectable or metastatic solid tumors who are either refractory after standard therapy for the disease or for whom standard therapy is not appropriate
Tumor with expected high expression of Fibroblast activation protein (FAP) of the following histologies: Non-small cell lung carcinoma (NSCLC), Gastric cancer, Esophageal adenocarcinoma or squamous cell carcinoma, Urothelial bladder carcinoma, Head and neck squamous cell carcinoma, Cutaneous malignant melanoma, Cutaneous squamous cell carcinoma, Hepatocellular carcinoma, Pancreatic adenocarcinoma, Colorectal cancer, Malignant pleural mesothelioma, Cervical squamous cell cancer, Ovarian carcinoma, Triple-negative breast cancer
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 36 months
Awards & highlights
Study Summary
This trial is testing a new cancer treatment to see if it is safe and effective. People with advanced cancer who have not had success with other treatments are eligible to participate. The treatment consists of a new medication, BI 765179, given alone or with another medication, ezabenlimab. The study will last up to three years, and participants will be closely monitored for any side effects.
Who is the study for?
Adults with advanced solid tumors that didn't respond to standard treatments or for whom such treatments aren't suitable can join. This includes those with certain types of cancers like lung, gastric, and breast cancer, among others. Participants must be over 18, have at least one measurable tumor outside the brain, be in good physical condition (ECOG 0 or 1), and have proper organ function. Women who can bear children and men who can father a child must use effective birth control.Check my eligibility
What is being tested?
The trial is testing the highest tolerable dose of BI 765179 alone or combined with ezabenlimab in patients with advanced cancer. Both drugs are antibodies designed to help the immune system fight cancer; this is the first time BI 765179 is being used on people. Treatments are given via infusion every three weeks for up to three years if beneficial and tolerable.See study design
What are the potential side effects?
While specific side effects aren't listed here, participants will be monitored regularly for any health problems related to treatment which could include typical antibody-related reactions like immune system complications, infusion reactions, fatigue or allergic responses.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My cancer is advanced and hasn't responded to standard treatments, or standard treatments aren't suitable for me.
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My cancer is expected to have high FAP expression.
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I am at least 18 years old or the legal age of consent in my country.
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I have a tumor outside the brain that can be measured.
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I am fully active or restricted in physically strenuous activity but can do light work.
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I am using or willing to use effective birth control during and 6 months after the study.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 36 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 36 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Maximum Tolerated Dose (MTD)
Number of patients experiencing Dose Limiting Toxicities (DLTs) in the MTD evaluation period
Secondary outcome measures
Area under the concentration-time curve of BI 765179 in plasma at steady state over a uniform dosing interval 504h (AUC0-504,ss)
Area under the concentration-time curve of BI 765179 in plasma over a uniform dosing interval from zero to 504h (AUC0-504)
Maximum measured concentration of BI 765179 in plasma (Cmax)
+2 moreTrial Design
2Treatment groups
Experimental Treatment
Group I: Arm B: BI 765179 + ezabenlimabExperimental Treatment2 Interventions
Group II: Arm A: BI 765179Experimental Treatment1 Intervention
Find a Location
Who is running the clinical trial?
Boehringer IngelheimLead Sponsor
2,509 Previous Clinical Trials
11,340,855 Total Patients Enrolled
3 Trials studying Tumors
1,624 Patients Enrolled for Tumors
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My side effects from past treatments are mild, except for hair loss, nerve pain, tiredness, or hormone issues treated with medication.My cancer is advanced and hasn't responded to standard treatments, or standard treatments aren't suitable for me.I have signed and understand the consent form for this trial.I have a tumor outside the brain that can be measured.I am fully active or restricted in physically strenuous activity but can do light work.My liver, kidneys, and bone marrow are working well.I am using or willing to use effective birth control during and 6 months after the study.I haven't taken strong immune-weakening medicines in the last 2 weeks, except for low-dose steroids or local treatments.I am on blood thinners that can't be stopped for medical procedures.My cancer is expected to have high FAP expression.My brain cancer is stable, I had treatment over 2 weeks ago, and I haven't used steroids or anti-epileptic drugs in the last 7 days.I am at least 18 years old or the legal age of consent in my country.My cancer has spread to the lining of my brain or spinal cord.I have had no other cancers in the last 2 years, except for certain treated skin, cervical, or ductal cancers.I have been treated with drugs targeting CD137 before.I have been diagnosed with an immune system disorder.
Research Study Groups:
This trial has the following groups:- Group 1: Arm A: BI 765179
- Group 2: Arm B: BI 765179 + ezabenlimab
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.
What is the total enrollment of this research project?
"Affirmative. The information on clinicaltrials.gov verifies that this investigation is currently enrolling patients and was initially published on September 24th 2021. 150 individuals need to be recruited across 2 sites, with a recent update done November 2nd 2022."
Answered by AI
Are recruitment efforts currently underway for this investigation?
"That's accurate. According to clinicaltrials.gov, this medical experiment began recruiting on September 24th 2021 and is still taking applications today as per its last update from November 2nd 2022. 150 volunteers are necessary for the project at two separate sites of study."
Answered by AI
Has the FDA sanctioned BI 765179 for public use?
"Due to its early stage status, BI 765179's safety can only be estimated at a score of 1. There is limited data available in terms of efficacy and overall security for this drug candidate."
Answered by AI
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