Clinical Trial Evaluating the Safety, Tolerability and Preliminary Efficacy of BNT116 Alone and in Combinations in Patients With Advanced Non-small Cell Lung Cancer

Trial status:Recruiting
Trial ID:
BNT116-01
NCT ID:
NCT05142189
EudraCT ID:
2021-004739-94
Sponsor:
The sponsor of a clinical trial is the company, institution or individual that takes responsibility for initiating, managing, and/or financing a clinical investigation. BioNTech collaborates with other pharmaceutical companies or institutions (collaborators) to develop certain new medicines. In particular cases BioNTech's collaborators are leading specific clinical trials and are acting as sponsors accordingly.
BioNTech SE
Recruiting

Trial Details

This first-in-human (FIH) trial 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, BNT316 (an anti-cytotoxic T-lymphocyte-associated protein 4 \[CTLA-4\] antibody), an anti-B7-H3 antibody conjugated to a topoisomerase I inhibitor, or an anti-human epidermal growth factor receptor 3 (HER3) antibody conjugated to a topoisomerase I inhibitor in patients with non-small cell lung cancer (NSCLC).

The trial will comprise of several cohorts for dose confirmation in monotherapy as well as in combinations of BNT116 as mentioned above.

The trial will enroll patients with NSCLC in advanced or metastatic stage in Cohorts 1 to 4 and Cohorts 7 to 9, unresectable NSCLC Stage III in Cohort 5, and resectable NSCLC of Stage II and III in Cohort 6.

Medical Condition
  • Lung Cancer
    • Trial Drug
  • BNT116
    • See more
  • BNT316
  • Cemiplimab
  • Docetaxel
  • Carboplatin
  • Paclitaxel
  • anti-B7-H3 antibody conjugated to topoisomerase I inhibitor
  • anti-HER3 antibody conjugated to topoisomerase I inhibitor
    • Phase
    Phase 1
    Type
    Interventional
    Estimated Enrolment
    220
    Estimated Trial Date
    Jun 2022 - Feb 2030

    Trial Participant Requirements

    Age
    18+ years
    Sex
    Female & Male
    Healthy Volunteers
    No

    Trial Locations

    Location
    Status
    Location
    University of Kentucky Chandler Medical Center
    Lexington, Kentucky, United States, 40536
    Status
    Recruiting
    Location
    Norton Cancer Institute
    Louisville, Kentucky, United States, 40202
    Status
    Recruiting
    Location
    Johns Hopkins Sidney Kimmel Comprehensive Cancer Center
    Baltimore, Maryland, United States, 21287
    Status
    Recruiting
    Location
    NEXT Virginia
    Fairfax, Virginia, United States, 22031
    Status
    Recruiting
    Location
    Scientia Clinical Research
    Randwick, New South Wales, Australia, 2031
    Status
    Not yet recruiting
    Location
    Cancer Research SA
    Adelaide, South Australia, Australia, 5000
    Status
    Not yet recruiting