Study Overview

The study is divided into two cohorts (Cohort 1 and Cohort 2), to which participants will be enrolled based on the amount of human epidermal growth factor receptor 2 (HER2) in their tumor sample. In Cohort 1, the main goal is to assess how well BNT323 (also known as DB-1303) or chemotherapy (doxorubicin or paclitaxel \[or docetaxel, if participants cannot take paclitaxel\]) works by determining the progression-free survival (PFS) of participants who have been previously treated with immune checkpoint inhibitors (ICIs). In Cohort 2, the main goal is to assess how well BNT323 works by determining the objective response rate (ORR), that is, the percentage of participants whose tumor shrinks (partial response) or disappears (complete response) after treatment. The safety of BNT323 will also be assessed by following the occurrence of unfavorable/adverse effects that are seen after treatment. Other measures include the pharmacokinetics of BNT323 (or how BNT323 moves through and out of the body), the body's immune response, and the impact on quality of life.

Full Details and Eligibility at clinicaltrials.gov

By taking part in a clinical trial, you have access to potentially effective treatments not available elsewhere. Additionally, you will contribute to cancer research, which can help other cancer patients in the future. Read the full details of this specific clinical trial by clicking on the link below.

clinicaltrials.gov NCT:NCT06340568

Interested in Participating in this Trial?

If you are interested in participating in this study, call the OSF Hope line at (844) 673- 4467 or email: sfmc.clinicaltrials@osfhealthcare.org