BI 907828 + Ezabenlimab (+/- BI 754111) for Advanced Cancer

Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: Boehringer Ingelheim

No Placebo Group

Trial Summary

What is the purpose of this trial?This study has 2 parts. The first part of the study is done. The first part was open to adults with different types of advanced cancer (solid tumors). The second part is open to people with specific types of soft tissue sarcoma, advanced lung cancer, and cancer in the stomach, bladder or bile ducts. The participants get a combination of 2 medicines called brigimadlin (also called BI 907828) and ezabenlimab (also called BI 754091). Brigimadlin is a so-called MDM2 inhibitor that is being developed to treat cancer. Ezabenlimab is an antibody that may help the immune system fight cancer (immune checkpoint inhibitor). When the study started, some participants got a third medicine called BI 754111 in addition. Treatment with BI 754111 was stopped because data from another study showed no additional effect of BI 754111. The purpose of the first part of the study was to find out the highest dose of brigimadlin that the participants could tolerate in combination with ezabenlimab. This dose is used in the second part of the study. The purpose of the second part is to see whether the combination of brigimadlin with ezabenlimab is able to make tumors shrink. The participants are in the study as long as they benefit from treatment and can tolerate it. Ezabenlimab treatment is limited to 2 years. During this time, they get infusions of ezabenlimab, and take tablets with brigimadlin every 3 weeks. The doctors check how many participants have health problems during the study. The doctors also monitor the size of the tumor.

Eligibility Criteria

Adults with various advanced cancers, including specific soft tissue sarcomas and lung, stomach, bladder or bile duct cancers. Participants must be over 18, have acceptable blood counts and organ function, not be pregnant or nursing, use reliable birth control if applicable, and cannot have other active malignancies or severe health conditions that could affect trial participation.

Inclusion Criteria

I am fully active or can carry out light work.

I have an advanced cancer that can't be removed by surgery and can provide a sample of my tumor.

My cancer has worsened or returned after all standard treatments, or I can't receive them.

I am fully active or can carry out light work.

Exclusion Criteria

I have not had any other cancer in the last 3 years.

I am currently experiencing bleeding or have a high risk of bleeding.

I have an autoimmune disease that needs treatment.

I have never taken BI 907828 or similar drugs targeting MDM2-p53 or MDMX-p53.

I do not have an active infection needing treatment when starting this trial.

I have brain metastases that are causing symptoms.

I have been diagnosed with HIV.

I haven't had major surgery in the last 3 months and don't plan any in the next year.

I haven't taken high doses of steroids like prednisone (more than 10 mg daily) in the last 4 weeks.

I am not pregnant, nursing, or planning to become pregnant during the trial.

Treatment Details

The study tests different doses of BI 907828 combined with ezabenlimab in patients with advanced cancer. The first part determines the highest tolerable dose; the second part assesses tumor shrinkage using this dose combination. Treatment includes infusions of ezabenlimab every three weeks alongside oral BI 907828 tablets.

4Treatment groups

Experimental Treatment

Group I: Dose Expansion - Cohort 2 - BI 907828 + ezabenlimabExperimental Treatment2 Interventions

Group II: Dose Expansion - Cohort 1 BI 907828 + ezabenlimabExperimental Treatment2 Interventions

Group III: Dose Escalation - BI 907828 + ezabenlimab + BI 754111Experimental Treatment3 Interventions

All neoplasms

Group IV: Dose Escalation - BI 907828 + ezabenlimabExperimental Treatment2 Interventions

All neoplasms