Immunotherapy with BI 1821736 for Advanced Cancer

Recruiting at 9 trial locations

Overseen By Boehringer Ingelheim

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Boehringer Ingelheim

Must not be taking: Corticosteroids, Interferon, Immunotherapy, Tamoxifen

Disqualifiers: Brain metastases, Active infection, others

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

Compensation: Varies

Number of Visits: 3

Duration: 12 weeks

10 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is for adults with advanced solid tumors who have no other treatment options. It tests a new medicine called BI 1821736, which uses a virus to kill cancer cells and boost the immune system. Participants receive the medicine regularly, and doctors monitor their health and any side effects.

Eligibility Criteria

Adults with advanced solid tumors that have not responded to previous treatments or for whom no treatment is available can join this trial. They must have a tumor lesion suitable for biopsy, normal blood clotting levels, and resolved side effects from past cancer therapies (except certain conditions). Participants need good organ function and an acceptable level of blood cells.

Inclusion Criteria

I have tried all known treatments for my condition without success.

My blood clotting times are normal or I'm on a stable blood thinner dose.

Further inclusion criteria apply

Exclusion Criteria

I have not taken more than 10 mg of prednisone or equivalent daily in the last 3 weeks.

I haven't taken any high-risk medications or have conditions that could complicate a biopsy recently.

Further exclusion criteria apply

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive BI 1821736 as an infusion into a vein about every 3 weeks for up to 3 months

12 weeks

Infusion every 3 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• BI 1821736

Trial Overview The trial is testing BI 1821736, a new immunotherapy given as an infusion every three weeks up to three months. It's the first time humans receive this virus-based therapy designed to kill cancer cells and boost the immune system. The highest tolerable dose will be determined while monitoring health and tumor response.

Participant Groups

Group I: BI 1821736: Dose escalation cohort Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Boehringer Ingelheim

Lead Sponsor

Trials

2,566

Recruited

16,150,000+