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RECRUITING
NCT07455734
PHASE1/PHASE2

Early-phase Trial to Assess the Safety and Preliminary Efficacy of BNT3214 in Adults With Advanced Solid Tumors

Sponsor: BioNTech SE

View on ClinicalTrials.gov

Summary

This study is the first time the drug BNT3214 (also referred to as PM8102) will be tested in people. It is designed to find out if the drug is safe and how well it works for adults with advanced solid tumors. The study will have three parts. The first two parts (Parts A and B) will focus on testing different amounts of BNT3214 to figure out the best and safest dose. The third part (Part C) will test selected doses of BNT3214 in multiple types of cancer.

Official title: A Phase I/IIa, First-in-human, Open-label, Multi-site, Multi-regional, Dose Escalation Trial With Expansion Cohorts to Evaluate Safety and Preliminary Efficacy of BNT3214 in Adults With Advanced Solid Tumors

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

533

Start Date

2026-03-30

Completion Date

2030-10

Last Updated

2026-07-09

Healthy Volunteers

No

Interventions

DRUG

BNT3214

Intravenous infusion

Locations (16)

Monash Medical Centre Clayton

Clayton, Australia

Austin Health

Heidelberg Heights, Australia

Peter MacCallum Cancer Centre

Melbourne, Australia

Scientia Clinical Research Ltd

Randwick, Australia

Epworth HealthCare

Richmond, Australia

Chongqing University Cancer Hospital

Chongqing, China

Nanfang Hospital of Southern Medical University

Guangzhou, China

Zhejiang Cancer Hospital

Hangzhou, China

Shanghai East Hospital

Shanghai, China

Tianjin Medical University Cancer Institute & Hospital

Tianjin, China

Seoul National University Bundang Hospital

Seongnam, South Korea

Seoul National University Hospital

Seoul, South Korea

Severance Hospital, Yonsei University Health System

Seoul, South Korea

Asan Medical Center

Seoul, South Korea

China Medical University Hospital

Taichung, Taiwan

National Taiwan University Hospital

Taipei, Taiwan