Condition: Non-Small Cell Lung Cancer · Sponsor: BioNTech SE
This first-in-human (FIH) study for BNT116 aims to establish the safety profile and a safe dose for BNT116 monotherapy as well as for BNT116 in combination with approved medicinal products and/or in combination with investigational medicinal products (IMPs) including, but not limited to, cemiplimab, docetaxel, carboplatin, paclitaxel, osimertinib, anaplastic lymphoma kinase (ALK) tyrosine kinase inhibitors (TKIs), rearranged during transfection (RET) TKIs, BNT316 (an anti-cytotoxic T-lymphocyte-associated protein 4 \[CTLA-4\] antibody), an anti-B7-H3 antibody conjugated to a topoisomerase I inhibitor, an anti-human epidermal growth factor receptor 3 (HER3) antibody conjugated to a topoisomerase I inhibitor or a bispecific antibody for programmed death ligand 1 (PD-L1) and vascular endothelial growth factor A (VEGF-A) in participants with non-small cell lung cancer (NSCLC). The study will comprise several cohorts for dose confirmation in monotherapy as well as in combinations of BNT116 as mentioned above. The study will enroll participants with NSCLC in advanced or metastatic stage in Cohorts 1 to 4 and Cohorts 7 to 10, unresectable NSCLC Stage III in Cohorts 5 and 11, resectable NSCLC of Stage II and III in Cohort 6, advanced/metastatic epidermal growth factor receptor (EGFR)-mutant NSCLC in Cohort EGFR, and advanced/metastatic ALK rearranged or RET rearranged NSCLC in Cohort ALK/RET. Cohort EGFR and Cohort ALK/RET will enroll only at selected sites in the US.
This description comes directly from the study's public registry record.
BioNTech clinical trials patient information · +49 6131 9084 · patients@biontech.de
Always discuss trial participation with your own doctor first.
| University of Kentucky Chandler Medical Center | Lexington, Kentucky, United States | Recruiting |
| Norton Cancer Institute | Louisville, Kentucky, United States | Recruiting |
| Johns Hopkins Sidney Kimmel Comprehensive Cancer Center | Baltimore, Maryland, United States | Recruiting |
| Ohio State University | Columbus, Ohio, United States | Recruiting |
| MD Anderson Cancer Center | Houston, Texas, United States | Recruiting |
| NEXT Virginia | Fairfax, Virginia, United States | Recruiting |
| Scientia Clinical Research | Randwick, New South Wales, Australia | Recruiting |
| Royal North Shore Hospital | Sydney, New South Wales, Australia | Recruiting |
| Cancer Research SA | Adelaide, South Australia, Australia | Recruiting |
| Monash Health | Clayton, Victoria, Australia | Recruiting |
| Universitätsklinikum Köln | Cologne, Germany | Recruiting |
| Krankenhaus Nordwest GmbH - Institut Fuer Klinisch-Onkologische Forschung (IKF) | Frankfurt, Germany | Recruiting |
+ 33 more locations — full list on the registry record.
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Source record: clinicaltrials.gov/study/NCT05142189