Clinical Trial Evaluating the Safety, Tolerability and Preliminary Efficacy of BNT116 Alone and in Combinations in Patients With Advanced Non-small Cell Lung Cancer
NCT05142189
This study is recruiting at 6 US sites in 5 states, according to its ClinicalTrials.gov record last updated .
Summary
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…
Shortened from the sponsor's brief summary. View official record on ClinicalTrials.gov
Conditions studied
- Non-Small Cell Lung Cancer
Eligibility basics and study details
- Study type
- Interventional
- Phase
- Phase 1
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Sponsor
- BioNTech SE
- Last updated on ClinicalTrials.gov
- July 22, 2026
These are the basic criteria only. The full inclusion and exclusion criteria are on the official record, and the study team decides who can take part.
US recruiting sites
Kentucky · 2
- University of Kentucky Chandler Medical Center · Lexington, KY
- Norton Cancer Institute · Louisville, KY
Maryland · 1
- Johns Hopkins Sidney Kimmel Comprehensive Cancer Center · Baltimore, MD
Ohio · 1
- Ohio State University · Columbus, OH
Texas · 1
- MD Anderson Cancer Center · Houston, TX
Virginia · 1
- NEXT Virginia · Fairfax, VA
Source: ClinicalTrials.gov, data processed . Recruiting US sites filtered by distance and site status; summaries shortened.