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

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
Adults

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
Christopher Hoimes
Protocol Number
IRB: PRO00112461
NCT: NCT05262530
Phase
Phase I/II
ClinicalTrials.gov
Enrollment Status
Open for Enrollment