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RECRUITING
NCT07147348
PHASE1/PHASE2

A First-in-human, Dose Escalation and Indication Expansion Study of BNT3212 as Monotherapy or in Combination With BNT327 in Adults With Advanced Solid Tumors

Sponsor: BioNTech SE

View on ClinicalTrials.gov

Summary

The aim of this first-in-human (FIH) open-label, multi-site study is to evaluate safety, tolerability, pharmacokinetics (PK), immunogenicity and preliminary clinical efficacy of BNT3212, including identification of the recommended dose of BNT3212 for use as monotherapy and with pumitamig (also known as BNT327 or PM8002) as combination therapy, in adults with advanced solid tumors who have exhausted other treatment options.

Official title: A Phase I/II, First-in-human, Open-label, Dose Escalation and Indication Expansion Study of the Safety, Tolerability, Pharmacokinetics, Immunogenicity and Preliminary Efficacy of BNT3212 as Monotherapy or in Combination With BNT327 in Adults With Advanced Solid Tumors

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

375

Start Date

2025-08-27

Completion Date

2028-08

Last Updated

2026-04-06

Healthy Volunteers

No

Interventions

BIOLOGICAL

BNT3212

Intravenous infusion

BIOLOGICAL

Pumitamig

Intravenous infusion

Locations (16)

Cancer Research SA

Adelaide, Australia

Monash Medical Centre

Clayton, Australia

Peter MacCallum Cancer Centre

Melbourne, Australia

The Alfred Hospital

Melbourne, Australia

One Clinical Research

Nedlands, Australia

Scientia Clinical Research Limited

Randwick, Australia

Beijing Cancer Hospital

Beijing, China

Anhui Provincial Hospital

Hefei, China

First Affiliated Hospital of Xinxiang Medical University

Henan, China

Hunan Province Cancer Hospital

Hunan, China

Shandong University-Jinan Central Hospital

Shandong, China

Linyi Tumor Hospital

Shandong, China

Shanghai East Hospital

Shanghai, China

Shanghai GoBroad Cancer Hospital

Shanghai, China

Sichuan Cancer Hospital

Sichuan, China

Zhejiang Cancer Hospital

Zhejiang, China