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
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.
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
View on ClinicalTrials.gov
Enrollment Status
Open for Enrollment