Immunotherapy for Advanced Cancer

Recruiting at 23 trial locations

Overseen By Boehringer Ingelheim

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Boehringer Ingelheim

Must not be taking: Corticosteroids, Anticonvulsants

Disqualifiers: CNS metastases, Autoimmune disease, Cardiovascular, others

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

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

212 Participants Needed

Trial Summary

What is the purpose of this trial?

This is a study in adults with various types of advanced cancer. The purpose of the study is to test a medicine called BI 754091 in combination with several other cancer medicines. BI 754091 is an immunotherapy. This means it may help the immune system fight cancer. Such therapies are also called immune checkpoint inhibitors. How long the participants are in the study depends on whether they benefit from treatment and whether they experience unacceptable side effects. The participants are put into different groups. Each group receives BI 754091 in combination with another medicine. The doctors check whether the tumors shrink or disappear. The doctors also check the general health of the participants.

Eligibility Criteria

Adults with advanced cancer, including gastric adenocarcinoma, metastatic solid tumors resistant to PD-1/PD-L1 therapy, colorectal cancer, and endometrial carcinoma. Participants must be over 18 years old with an ECOG score of 0 or 1 and a life expectancy of at least 12 weeks. They should have measurable lesions and agree to tumor biopsies. Women who can bear children and men must use effective birth control.

Inclusion Criteria

Life expectancy of at least 12 weeks after the start of the treatment according to the Investigator's judgement.

I agree to have tumor biopsies before and during treatment.

My cancer type has been confirmed by a lab test.

Exclusion Criteria

You have had serious allergic reactions to other similar medications or to the drugs being used in the trial.

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

I have an autoimmune disease but it's not vitiligo or resolved childhood asthma.

Treatment Details

Interventions

• BI 754091
• BI 754111
• BI 836880

Trial Overview The trial is testing BI 754091 combined with other cancer medicines in adults with various advanced cancers. BI 754091 is an immunotherapy designed to boost the immune system's ability to fight cancer. The study will monitor if this combination leads to tumor shrinkage or disappearance while also checking participants' overall health.

Participant Groups

Group I: Cohort 5 - Module C Experimental Treatment 2 Interventions

Group II: Cohort 4 - Module C Experimental Treatment 2 Interventions

Group III: Cohort 3 - Module C Experimental Treatment 2 Interventions

Group IV: Cohort 3 - Module A Experimental Treatment 2 Interventions

Group V: Cohort 2 - Module C Experimental Treatment 2 Interventions

Group VI: Cohort 2 - Module A Experimental Treatment 2 Interventions

Group VII: Cohort 1 - Module C Experimental Treatment 2 Interventions

Group VIII: Cohort 1 - Module A Experimental Treatment 2 Interventions

Who Is Running the Clinical Trial?

Boehringer Ingelheim

Lead Sponsor

Trials

2,566

Recruited

16,150,000+