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NOT YET RECRUITING
NCT07893054
PHASE1

A First-in-human Clinical Trial to Test if the Investigational Drug BNT3219 is Safe and Potentially Beneficial for People With Advanced Solid Tumors When Given Alone or Together With Other Investigational Drugs

Sponsor: BioNTech SE

View on ClinicalTrials.gov

Summary

This study will test BNT3219 (also known as PM1092) in adults with advanced solid tumors whose cancer has progressed after available standard treatments. It is the first study of BNT3219 in people, and it will test different dose levels to identify safe and tolerable doses. The study will also examine how the treatment moves through the body, whether the immune system reacts to them, and whether it shows signs of shrinking or controlling tumors.

Official title: A Phase I/Ib, First-in-human, Open-label, Multi-site, Multi-regional, Dose Escalation Trial With Expansion Cohorts to Evaluate Safety and Preliminary Efficacy of BNT3219 Monotherapy or BNT3219 in Combination With Other Investigational Therapies in Participants With Advanced Solid Tumors

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

207

Start Date

2026-11

Completion Date

2030-10

Last Updated

2026-10-23

Healthy Volunteers

No

Interventions

DRUG

BNT3219

Solution for intravenous (IV) infusion