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Safety and Preliminary Efficacy Trial of BNT142 in Patients With CLDN6-positive Solid Tumors

Solid Tumor Clinical Trial

Official 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

Clinical Trial Summary

This study is an open-label, multicenter, Phase I/IIa, dose escalation, safety, and pharmacokinetics (PK) study of BNT142 followed by expansion cohorts in patients with Claudin 6 (CLDN6)-positive advanced tumors.

Clinical Trial Description

Part 1 (Dose escalation) of this study is a first-in-human (FIH), open-label, dose escalation safety and PK study of BNT142 in patients with advanced/metastatic CLDN6-positive solid tumors. Part 2 (Expansion) will be a Phase IIa proof-of-concept study in up to three expansion cohorts of CLDN6 positive advanced/metastatic ovarian cancer, non-small cell lung cancer (NSCLC) of non-squamous type, and testicular cancer patients who have progressed on or after last prior treatment. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05262530
Study type Interventional
Source BioNTech SE
Contact BioNTech clinical trials patient information
Phone +49 6131 9084
Email patients@biontech.de
Status Recruiting
Phase Phase 1/Phase 2
Start date March 28, 2022
Completion date April 2026
View Details
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