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

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).

Who Can Participate?

Eligibility

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
Eligible study candidates must also have received all available standard therapies for treatment and 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.

What is Involved?

Description

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

Christopher
Hoimes

Protocol Number

PRO00112461

NCT ID

NCT05262530

Phase

I/II

Enrollment Status

Open to Enrollment
ClinicalTrials.gov