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
Study Identifier:
BNT116-01
ClinicalTrials.gov Identifier:
NCT05142189
EudraCT Identifier:
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

Medical Condition
  • Lung Cancer
    • Study Drug
  • Biological: BNT116
  • Biological: Cemiplimab
  • Drug: Docetaxel
    • See more
  • Drug: Carboplatin
  • Drug: Paclitaxel
  • Biological: CTLA4 antibody
    • Phase
    Phase 1
    Sex
    Female & Male
    Age
    18+ years
    Estimated Trial Date
    Jun 2022 - Apr 2027

    Protocol summary

    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 other therapies (cemiplimab, docetaxel, or a cytotoxic T-lymphocyte-associated protein 4 \[CTLA4\] antibody \[another investigational medicinal product\]) in patients with advanced or metastasized non-small cell lung cancer (NSCLC) and unresectable NSCLC after chemoradiotherapy (CRT). Furthermore, the trial aims to establish the safety and feasibility of BNT116 in combination with cemiplimab and chemotherapy (carboplatin+paclitaxel) as neo-adjuvant treatment in resectable NSCLC followed by surgery and adjuvant BNT116 + cemiplimab. The trial will comprise several cohorts for dose confirmation in monotherapy as well as in combinations of BNT116 as mentioned above.

    Trial locations

    Location
    Status
    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
    Krankenhaus Nordwest GmbH - Institut Fuer Klinisch-Onkologische Forschung (IKF)
    Frankfurt, Germany, 60488
    Status
    Recruiting
    Location
    University Medical Center Hamburg-Eppendorf
    Hamburg, Germany, 20246
    Status
    Recruiting
    Location
    Universitätsklinikum Köln
    Köln, Germany, 50937
    Status
    Recruiting