Your session is about to expire
← Back to Search
Monoclonal Antibodies
BI 765049 + Ezabenlimab for Advanced Solid Cancers
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
Signed and dated, written informed consent form (ICF) (ICF1 for B7-H6 testing for all patients except those with advanced or metastatic colorectal cancer (CRC); and ICF2 for all patients) describing the study in accordance with International Council on Harmonisation Good Clinical Practice (ICH-GCP) and local legislation prior to any trial-specific procedures, sampling, or analyses.
Patient must be ≥18 years of age at the time of signature on the ICFs (ICF1 and ICF2).
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 36 months
Awards & highlights
Study Summary
This trial is for adults with advanced solid tumors whose previous cancer treatment was not successful. People with the B7-H6 marker or colorectal cancer are eligible. The study is testing two medicines, BI 765049 and BI 754091, which may help the immune system fight cancer. The purpose is to find the highest tolerable dose of BI 765049 given alone and in combination with BI 754091. Participants can stay in the study for up to three years and will receive BI 765049 and BI 754091 through IV infusions every three weeks. Doctors will monitor participants' health and tumor size throughout the trial
Who is the study for?
Adults with advanced solid tumors that have not responded to standard treatments can join this trial. Eligible cancers include colorectal, lung, liver, head and neck, stomach, and pancreatic cancers. Participants must have a specific tumor marker (B7-H6) or colorectal cancer and be in good enough health to undergo biopsies.Check my eligibility
What is being tested?
The study is testing two drugs: BI 765049 alone and combined with ezabenlimab. It aims to find the highest dose patients can tolerate over up to three years of treatment given every three weeks via infusion. The effects on the immune system's ability to fight cancer are monitored along with tumor size.See study design
What are the potential side effects?
Potential side effects from BI 765049 or ezabenlimab may include reactions related to the immune system attacking normal organs (autoimmune reactions), issues at the infusion site, fatigue, nausea, and increased risk of infections.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have signed the required consent forms for my participation in the study.
Select...
I am 18 years old or older.
Select...
I have advanced cancer that cannot be removed by surgery in specific areas like the colon, lung, liver, head and neck, stomach, or pancreas.
Select...
I am fully active or can carry out light work.
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) in any studied regimen
Number of patients with dose limiting toxicities (DLTs) in the maximum tolerated dose (MTD) evaluation period
Secondary outcome measures
Area under the concentration-time curve of BI 765049 over a uniform dosing interval τ (AUCτ)
Maximum measured concentration of BI 765049 (Cmax)
Objective response based on Response Evaluation Criteria in Solid Tumors (RECIST v1.1) in patients with measurable disease
Trial Design
2Treatment groups
Experimental Treatment
Group I: BI 765049 single treatment groupExperimental Treatment1 Intervention
BI 765049
Group II: BI 765049 + ezabenlimab combination treatment groupExperimental Treatment2 Interventions
BI 765049 + ezabenlimab
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
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have advanced cancer that cannot be removed by surgery in specific areas like the colon, lung, liver, head and neck, stomach, or pancreas.You have hepatitis C virus in your blood.I have signed the required consent forms for my participation in the study.I have not had any major surgeries within the last 28 days.I have a measurable cancer lesion outside the brain that hasn't been treated with radiation.I haven't taken any cancer drugs or experimental drugs within the last 21 days or 5 half-lives before starting BI 765049.My cancer has worsened despite treatment, or I can't undergo standard treatment.I agree to provide tumor samples for research.I am fully active or can carry out light work.I need anticoagulant treatment that can't be stopped for study procedures.I have taken antibiotics for an infection within the last week.You have a positive hepatitis B surface antigen test.I have hepatitis B as shown by specific tests.I have a history of previous treatments.I have not had extensive radiotherapy, including to the brain, in the last 14 days.You have HIV.You have evidence of hepatitis virus infection in recent test results.I had cancer before, but it was treated and considered cured within the last 2 years.I have advanced colorectal cancer or my tumor shows B7-H6 expression.I am 18 years old or older.I have cancer that has spread to the lining of my brain or spinal cord, or is pressing on my spinal cord.
Research Study Groups:
This trial has the following groups:- Group 1: BI 765049 + ezabenlimab combination treatment group
- Group 2: BI 765049 single treatment group
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 there still opportunities for individuals to join this clinical experiment?
"Affirmative. According to information found on clinicaltrials.gov, this medical trial is actively looking for participants and was initially posted in May 2021 with the most recent update taking place in November 2022. The study needs 120 patients from 5 different locations."
Answered by AI
What is the size of the cohort involved in this research endeavor?
"This clinical trial requires 120 people who meet the predefined eligibility criteria. Those interested in participating can do so at HealthONE located in Denver, Colorado or Stephenson Cancer Center situated in Oklahoma City, Oklahoma."
Answered by AI
How does BI 765049 affect patient safety?
"Our assessment of BI 765049's safety is a 1. This evaluation was made due to this being an early Phase 1 trial, which has limited data regarding both efficacy and safety."
Answered by AI
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger