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Life sciences · Phase 1/2 Trial
ClinicalTrials.gov · October 22, 2026
No summary has been generated for this record yet. What follows is drawn from its source metadata only.
Phase 1/2 Trial.
No findings were extractable from the material analysed.
Safety was not reported in the material analysed. Check the source before drawing any conclusion about harm.
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Registry record from ClinicalTrials.gov (NCT07111520). This is a study registration, not published results. Lead sponsor: BioNTech SE. Recruitment status: RECRUITING. Phase: PHASE1, PHASE2. Study type: INTERVENTIONAL. Enrollment: 880 participants (ESTIMATED). Conditions: Non-small Cell Lung Cancer. Interventions: DRUG: BNT326; DRUG: Pumitamig. Primary outcome measures: Part 1 - Occurrence of dose limiting toxicities (DLTs) within a participant , 21 days starting on Day 1 of Cycle 1; Part 1 and Part 2a - Occurrence of treatment emergent adverse events (TEAEs), treatment-related adverse events (TRAE), treatment emergent serious adverse events (TESAE), treatment-related serious adverse events (TRSAE) , from the first dose of investigational medicinal product (IMP) up to 90 days after the last dose of IMP or until a new systemic anti-cancer therapy is started, whichever occurs first (up to a maximum of 27 months); Part 1 and Part 2a - Occurrence of dose interruption, reduction, and discontinuation due to TEAEs , from the first dose of IMP up to 90 days after the last dose of IMP or until a new systemic anti-cancer therapy is started, whichever occurs first (up to a maximum of 27 months); Part 2a and Part 2b - Objective response rate (ORR) , from the time of initiation of the first dose of IMP to approximately 36 months. Brief 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 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.