RecruitingPhase 1Phase 2NCT07455734

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

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


Sponsor

BioNTech SE

Enrollment

533 participants

Start Date

Mar 30, 2026

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called BNT3214 for people with advanced solid tumor cancer. The study is currently recruiting participants at 5 locations. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGBNT3214

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

View Full Details on ClinicalTrials.gov

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NCT07455734


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