NCT05262530

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

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

• Status: Terminated
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 73 (actual)
• Sponsor: BioNTech SE · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Solid Tumor

Interventions

Type	Name	Description
BIOLOGICAL	BNT142	Intravenous bolus/infusion

Timeline

• Start date: 2022-03-22
• Primary completion: 2025-12-22
• Completion: 2025-12-22
• First posted: 2022-03-02
• Last updated: 2026-04-08

Locations

18 sites across 4 countries: United States, Singapore, Spain, United Kingdom

Regulatory

• FDA-regulated drug study