BioNTech BNT142-01 (Solid Tumor Cancers with CLDN6 Protein)

What is the Purpose of this Study?

We are doing this study to find out if an experimental drug called BNT142 (the study drug) is a safe and effective treatment for select cancers with solid tumors that test positive for a protein called Claudin 6 (CLDN6).

What is the Condition Being Studied?

Solid Tumor Cancers that Express the Protein Claudin 6 (CLDN6)

Who Can Participate in the Study?

Adults ages 18+ who:

  • Are diagnosed with one of the following types of solid tumor cancers:
    • Ovarian cancer; OR
    • Non-small cell lung cancer; OR
    • endometrial cancer; OR
    • Testicular cancer
  • Have received all available standard therapies for treatment
  • Test positive for the presence of CLDN6

For more information about who can join this study, please contact the study team at 919-681-6468.

Age Group

What is Involved?

If you choose to join this study, you will:

  • Have a tumor biopsy to test the tissue for CLDN6
  • Receive the study drug through an intravenous (IV) infusion
  • Have physical exams, blood draws, and give urine samples
  • Have imaging scans (CT and/or MRI)
  • Have heart tests (ECG)

Study Details

Full Title
First-in-human, open-label, multicenter, Phase I/IIa, dose escalation trial with expansion cohorts to evaluate safety and preliminary efficacy of BNT142 in patients with CLDN6-positive advanced solid tumors
Principal Investigator
Instructor in the Department of Medicine
Protocol Number
IRB: PRO00112461
NCT: NCT05262530
Phase I/II
Enrollment Status