BI 765049 + Ezabenlimab for Advanced Solid Cancers

No longer recruiting at 15 trial locations

Overseen By additional contact: Sarah Cannon Development Innovations

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Boehringer Ingelheim

Must not be taking: Anticoagulants, Antimicrobials

Disqualifiers: Major surgery, Other malignancies, HIV, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

Duration: Up to 3 years

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to find the highest safe dose of a new medicine, BI 765049, both alone and with another medicine, ezabenlimab (also known as BI 754091), to help the immune system fight advanced solid cancers. It targets individuals whose previous cancer treatments were ineffective and who have tumors with a specific marker called B7-H6 or have colorectal cancer. Participants will receive these medicines intravenously every three weeks for up to three years, as long as the treatment benefits them and remains tolerable. A suitable candidate for this trial might have advanced colorectal cancer or another advanced solid tumor that has not responded to standard treatments. As a Phase 1 trial, this research seeks to understand how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you are on a systemic anti-cancer therapy or investigational drug, you must stop it at least 21 days or 5 half-lives before starting the trial treatment.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that BI 765049 is a new drug designed to help the immune system target cancer cells. It connects to a specific marker on tumors and T cells, which are part of the immune system. Since this is the first time people are receiving BI 765049, the main goal is to determine the maximum safe dosage without causing major side effects.

This study also tests how well people tolerate BI 765049 when used with ezabenlimab, another medicine that helps the immune system fight cancer. As this is an early phase of the study, researchers are still collecting safety data. Participants receive close monitoring for any health issues. The researchers aim to find the right dose that patients can handle without too many side effects.

Because this is an initial trial, the safety data remains limited. However, the study's occurrence indicates that the treatment has passed initial safety checks in lab settings. Participants are carefully observed to ensure their safety as more data becomes available. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about BI 765049 and ezabenlimab because these treatments offer a novel approach to tackling advanced solid cancers. Unlike traditional treatments like chemotherapy and standard immunotherapy, BI 765049 is designed to target specific tumor microenvironments, potentially improving the immune system's ability to fight cancer cells. Ezabenlimab, on the other hand, is a checkpoint inhibitor that helps unleash the immune system by blocking the PD-1 pathway, which cancers often exploit to evade detection. Together, these treatments could offer a more precise and effective option for patients, with the promise of better outcomes and potentially fewer side effects.

What evidence suggests that this trial's treatments could be effective for advanced solid cancers?

Research has shown that BI 765049 is a promising new treatment for advanced solid tumors. It enhances the ability of the body's immune cells, known as T-cells, to attack cancer cells with a specific marker called B7-H6. Early studies have demonstrated potential by linking cancer cells and T-cells, aiming to strengthen the body's defense against cancer. In this trial, some participants will receive BI 765049 alone, while others will receive it in combination with another treatment, Ezabenlimab. This combination might further boost the immune system's ability to fight cancer. Although human studies have provided limited information, this approach offers hope for patients whose previous treatments were ineffective. ^{1 2 3 4 6}

Are You a Good Fit for This Trial?

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.

Inclusion 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.

I have signed the required consent forms for my participation in the study.

I have a measurable cancer lesion outside the brain that hasn't been treated with radiation.

Exclusion Criteria

You have hepatitis C virus in your blood.

I have not had any major surgeries within the last 28 days.

I haven't taken any cancer drugs or experimental drugs within the last 21 days or 5 half-lives before starting BI 765049.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive BI 765049 alone or in combination with ezabenlimab as infusion every 3 weeks

Up to 3 years

Infusion every 3 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• BI 754091
• BI 765049

Trial Overview

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.

How Is the Trial Designed?

Group I: BI 765049 single treatment group Experimental Treatment 1 Intervention

BI 765049

Group II: BI 765049 + ezabenlimab combination treatment group Experimental Treatment 2 Interventions

BI 765049 + ezabenlimab

Who Is Running the Clinical Trial?

Boehringer Ingelheim

Lead Sponsor

Trials

2,566

Recruited

16,150,000+

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT04752215

NCT04752215 | A Study Evaluating Different Doses of BI ...

The purpose of this study is to find out the highest dose of BI 765049 alone and in combination with ezabenlimab the participants can tolerate.

2.

ascopubs.org

ascopubs.org/doi/10.1200/JCO.2022.40.16_suppl.TPS3175

A first-in-human phase I dose-escalation trial of the B7-H6/ ...

BI 765049 is a novel IgG-like bispecific T-cell engager (TcE) designed to bind simultaneously to B7-H6 on tumor cells and CD3 on T cells, resulting in ...

3.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06882746

A Study to Test Different Doses of BI 765049 in People ...

The study aims to find the highest dose for the study medicine called BI 765049 that people with advanced cancer can tolerate. Another purpose is to find ...

4.

medinfo.boehringer-ingelheim.com

medinfo.boehringer-ingelheim.com/us/sites/default/files/2022-11/ph1%20trial%20of%20bi%20765049%20%20bi%20754091%20in%20patients%20with%20advanced%20solid%20tumors%20expressing%20b7-h6.pdf

A first-in-human Phase I dose-escalation trial of the B7-H6/ ...

BI 765049 ± ezabenlimab (BI 754091) in patients with advanced solid tumors expressing B7-H6. Presented at the American Society for Clinical Oncology (ASCO) ...

5.

asco.org

asco.org/abstracts-presentations/ABSTRACT443750

A phase Ia/Ib, non-randomized, open-label, dose ...

A phase Ia/Ib, non-randomized, open-label, dose escalation and expansion trial of the B7-H6/CD3 T-cell engager BI 765049 with or without ezabenlimab in Asian ...

6.

sciencedirect.com

sciencedirect.com/science/article/pii/S0168827825024559

New targets and new drugs for hepatobiliary cancers

Ongoing trials are investigating this target in advanced solid tumours, including studies of allogeneic memory-enriched CAR-T cells, which have ...