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).
Aged ≥18 years at the time of giving informed consent.
Have measurable disease defined by RECIST v1.1.
All participants have to provide a tumor tissue sample (e.g. Formalin-fixed paraffin-embedded [FFPE] slides or block) from archival tissue. Alternatively, a fresh biopsy should be collected, unless medically not justifiable to be conducted.
Have Eastern Cooperative Oncology Group performance status of 0 or 1.
Had disease progression on or were intolerant to prior treatment with an agent targeting HER3 (including antibody, ADC, cell therapy, and other drugs) or with a topoisomerase I inhibitor payload (including topoisomerase I inhibitor-containing ADCs). Note: For Part 2a Cohort A, prior exposure to agents targeting HER3 or topoisomerase I inhibitor payload may be allowed on a case-by-case basis after discussion with and approval by the sponsor.
Bleeding diathesis or active hemorrhage
Active infection, including respiratory viral infection
Child-Pugh class B or C cirrhosis
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Treatment groupsSee each treatment group below.
BioNTech SE
Lead sponsor
MediLink Therapeutics (Suzhou) Co., Ltd.
Collaborator