A Phase Ib/II, Multi-site, Open-label, Dose Finding Trial to Evaluate the Safety, Efficacy, and Pharmacokinetics of BNT326 in Combination With BNT327 in Participants With Advanced Non-small Cell Lung Cancer (NSCLC)
BioNTech SE
Summary
This is a multi-site, open-label, dose-finding study, consisting of Parts 1, 2a, and 2b to investigate the combination of BNT326 with BNT327 in participants with relapsed, progressive as well as treatment-naïve, advanced/metastatic non-small cell lung cancer (NSCLC). This study will enroll adult participants with histologically or cytologically confirmed NSCLC that is advanced (i.e., either metastatic or recurrent tumors with no known curative treatment available).
Description
Part 1 is a dose escalation to evaluate and establish two or three safe combination dose levels (DL1 and DL2 and optionally DL3) of BNT326 with BNT327. Part 2a is a dose expansion to evaluate the preliminary efficacy, safety, and tolerability. Part 2b is a dose optimization and contribution of components part. Parts 1 and 2a (Cohort A) will enroll participants with previous exposure to therapy for advanced/metastatic disease. Part 2a (Cohort B) and Part 2b (Cohorts C and D) will enroll less heavily pre-treated participants, namely those without prior systemic treatment for advanced/metastat…