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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 below
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I have signed the required consent forms for my participation in the study.
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I am 18 years old or older.
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I have advanced cancer that cannot be removed by surgery in specific areas like the colon, lung, liver, head and neck, stomach, or pancreas.
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I am fully active or can carry out light work.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 36 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 36 months for reporting.

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
11,340,454 Total Patients Enrolled

Media Library

BI 754091 (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04752215 — Phase 1
Cancer Research Study Groups: BI 765049 + ezabenlimab combination treatment group, BI 765049 single treatment group
Cancer Clinical Trial 2023: BI 754091 Highlights & Side Effects. Trial Name: NCT04752215 — Phase 1
BI 754091 (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04752215 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

In what locations can this research be found?

"Participants for this study can join at HealthONE in Denver, Stephenson Cancer Center in Oklahoma City and Tennessee Oncology PLLC in Nashville as well as 5 other centers."

Answered by AI

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
~32 spots leftby May 2025