NCT05839600

A Study to Find a Suitable Dose of BI 1821736 and Test Whether it Helps People With Advanced Cancer

An Open-label, Phase I Dose Escalation and Expansion Trial to Investigate Safety and Efficacy of BI 1821736 in Patients With Advanced Solid Tumors

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Boehringer Ingelheim · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is open to adults with advanced solid tumours. People with solid tumours for whom previous treatment was not successful or no treatment exists can take part. The purpose of this study is to find the highest dose of a medicine called BI 1821736 that people with advanced solid tumours can tolerate. BI 1821736 is a type of immunotherapy. It is a special virus that kills cancer cells and helps the immune system fight cancer. In this study, BI 1821736 is given to humans for the first time. Participants receive BI 1821736 as an infusion into a vein about every 3 weeks for up to 3 months. Study doctors regularly check the participants' health and monitor the tumours. The doctors also take note of any unwanted effects that could have been caused by BI 1821736.

Conditions

• Solid Tumors

Interventions

Type	Name	Description
DRUG	BI 1821736	Solution for infusion

Timeline

• Start date: 2023-06-07
• Primary completion: 2025-04-10
• Completion: 2025-04-10
• First posted: 2023-05-03
• Last updated: 2025-07-08

Locations

7 sites across 4 countries: United States, Canada, Spain, Sweden

Regulatory

• FDA-regulated drug study