A Study to Find the Best Dose of BI 1387446 Alone or in Combination With Ezabenlimab (BI 754091) in Patients With Different Types of Advanced or Metastatic Cancer (Solid Tumors)
- Registration Number
- NCT04147234
- Lead Sponsor
- Boehringer Ingelheim
- Brief Summary
This is a study in adults with advanced cancer (solid tumours) in whom previous treatment was not successful. The study tests 2 medicines called BI 1387446 and BI 754091. Both medicines may help the immune system fight cancer. In this study, BI 1387446 is given to humans for the first time.
The purpose of this study is to find out the highest dose of BI 1387446 alone and in combination with BI 754091 the participants can tolerate. BI 1387446 is injected directly into the tumour.
Participants get BI 1387446 injections every week at the beginning and then every 3 weeks.
Some participants get BI 754091 in addition to BI 1387446. BI 754091 is given as an infusion into a vein every 3 weeks.
As long as they benefit from treatment and can tolerate it, participants can stay in the study for up to 2 years and 8 months. During this time, they visit the study site regularly. At these visit, doctors record any unwanted effects. The doctors also regularly check participants' health.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 39
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm A: BI 1387446 BI 1387446 superficial lesions Arm B: BI 1387446 in combination with ezabenlimab (BI 754091) BI 1387446 superficial lesions Arm B: BI 1387446 in combination with ezabenlimab (BI 754091) BI 754091 superficial lesions
- Primary Outcome Measures
Name Time Method Maximum tolerated dose (MTD) based on number of Dose-limiting toxicities (DLTs) 3 weeks Number of patients with Dose limiting Toxicity (DLT) in the Maximum tolerated dose (MTD) evaluation period up to 3 weeks
- Secondary Outcome Measures
Name Time Method Objective response An average of 1 year Best percentage change from baseline in size of injected target lesions An average of 1 year Best percentage change from baseline in size of non-injected target lesions An average of 1 year
Trial Locations
- Locations (7)
Hospital Vall d'Hebron-Barcelona-47683
🇪🇸Barcelona, Spain
Froedtert and The Medical College of Wisconsin
🇺🇸Milwaukee, Wisconsin, United States
CIO Clara Campal
🇪🇸Madrid, Spain
Hospital Clínico de Valencia
🇪🇸Valencia, Spain
The Royal Marsden Hospital, Chelsea
🇬🇧London, United Kingdom
Churchill Hospital
🇬🇧Oxford, United Kingdom
The Royal Marsden Hospital, Sutton
🇬🇧Sutton, United Kingdom