A Study to Test How Well Different Doses of BI 1831169 in Combination With an Anti-PD1 Antibody Are Tolerated in Japanese People With Different Advanced Cancers
- Registration Number
- NCT07176975
- Lead Sponsor
- Boehringer Ingelheim
- Brief Summary
This study is open to Japanese adults with different types of advanced cancer (solid tumors). People can join the study if their cancer has spread, and previous treatments were not successful or no treatments exist.
The purpose of this study is to find the highest dose of a medicine called BI 1831169 that people can tolerate when taken together with an anti-PD1 antibody. The anti-PD1 antibody is already used to treat different cancers. Participants receive BI 1831169 together with an anti-PD1 antibody, which is given as an infusion into a vein for up to 1 year.
Participants visit the study site regularly. The number of site visits vary based on the study part and treatment response. Some visits include an overnight stay. The doctors regularly check the participants' health and monitor the tumors. The doctors also take note of any health problems that could have been caused by the study treatment.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 46
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Dose escalation part: BI 1831169 dose level 1 + anti-PD-1 antibody BI 1831169 - Dose escalation part: BI 1831169 dose level 1 + anti-PD-1 antibody nivolumab - Dose escalation part: BI 1831169 dose level 2 + anti-PD-1 antibody BI 1831169 - Dose escalation part: BI 1831169 dose level 3 + anti-PD-1 antibody nivolumab - Dose escalation part: BI 1831169 dose level 4 + anti-PD-1 antibody BI 1831169 - Dose expansion part: BI 1831169 + anti-PD-1 antibody BI 1831169 - Dose escalation part: BI 1831169 dose level 2 + anti-PD-1 antibody nivolumab - Dose escalation part: BI 1831169 dose level 3 + anti-PD-1 antibody BI 1831169 - Dose escalation part: BI 1831169 dose level 4 + anti-PD-1 antibody nivolumab - Dose expansion part: BI 1831169 + anti-PD-1 antibody nivolumab -
- Primary Outcome Measures
Name Time Method Occurrence of dose limiting toxicities (DLTs) during the maximum tolerated dose (MTD) evaluation period up to 6 weeks
- Secondary Outcome Measures
Name Time Method Occurrence of dose limiting toxicities (DLTs) during the on-treatment period. up to 12 months Occurrence of adverse events (AEs) during the on-treatment period up to 12 months
Trial Locations
- Locations (1)
National Cancer Center Hospital East
🇯🇵Chiba, Kashiwa, Japan
National Cancer Center Hospital East🇯🇵Chiba, Kashiwa, Japan