BioNTech SE
This is a multi-site, open-label, dose-finding study, consisting of Parts 1, 2a, and 2b to investigate the combination of BNT326 with pumitamig (also known as BNT327 or PM8002) 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). The main goals of this study are: 1. To find the best dose levels (DLs) for the combination of BNT326 and pumitamig. 2. To look at how well participants with advanced NSCLC tolerate the combination therapy (for example, which side effects participants experience and how severe they are). 3. To look at how well the combination therapy works to shrink the tumor in participants with advanced NSCLC.
Part 1 is a combination dose finding part. Participants will receive one of six combination DLs to evaluate and establish safe combination DLs of BNT326 with pumitamig, and to define the recommended Phase 2 combination dose. Part 2a is a dose expansion part to evaluate the preliminary efficacy, safety, and tolerability. Part 2b is a randomized dose optimization and contribution of components part. Parts 1, Part 2a (Cohort A) and Part 2b (Cohort C) will enroll participants with previous exposure to therapy for advanced/metastatic disease. Part 2a (Cohort B) and Part 2b (Cohort D) will enroll…
Key Inclusion Criteria (applicable to all participants and all parts unless otherwise specified): * Aged ≥18 years at the time of giving informed consent. Local laws will be followed if the age of consent is older. * Have measurable disease defined by RECIST v1.1. * Have Eastern Cooperative Oncology Group performance status of 0 or 1. * Have adequate organ and bone marrow function within 7 days before randomization/enrollment as defined in the protocol. * Have advanced (i.e., metastatic or locally recurrent where local therapy with curative intent is not possible) non-squamous or squamous NSC…
intravenous (IV) infusion
IV infusion