BNT326-01 is a Phase Ib/II, multi-site, open-label, dose-finding trial evaluating the safety, efficacy, and pharmacokinetics of BNT326 (anti-Her3 mAb) in combination with BNT327 (anti-VEGF-A antibody fused with an anti-PD-L1 antibody). The study enrolls adult participants diagnosed with advanced non-small cell lung cancer (NSCLC). The primary objectives are to assess the safety profile and to determine the recommended dose for the combination therapy. Secondary endpoints include the evaluation of objective response rates and the pharmacokinetic properties of both investigational agents. As an open-label trial, all eligible participants receive the experimental combination treatment. This study provides critical data on the clinical activity and tolerability of dual targeting in advanced stages of NSCLC.
This clinical trial evaluates whether the combination of two investigational drugs, BNT326 (anti-Her3 antibody) and BNT327 (anti-VEGF-A antibody fused with an anti-PD-L1 antibody), is safe and potentially effective for people with advanced non-small cell lung cancer. As a Phase Ib/II multi-site study, it aims to determine the appropriate dosage and monitor how patients tolerate the treatment. Adult participants with advanced stages of the disease may be eligible to join. The study focuses on understanding how the drugs move through the body and whether they can successfully help fight the cancer. All participants in this open-label trial will receive the study medication, as there is no placebo group. These findings are intended to support the development of new treatment options for patients with this type of lung cancer.
