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.
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.
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
Clinically significant 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