BI 765049 + Ezabenlimab for Advanced Solid Cancers

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

67 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial is testing two new drugs that may help the immune system fight cancer in adults with advanced solid tumors that didn't respond to previous treatments. The drugs aim to boost the body's natural defenses to better attack cancer cells.

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+