RecruitingPhase 1Phase 2NCT07147348

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

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


Sponsor

BioNTech SE

Enrollment

375 participants

Start Date

Aug 27, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new cancer immunotherapy drug called BNT3212, either alone or combined with another drug (BNT327), in adults with advanced solid tumors. It is a first-in-human study, meaning this drug is being tested in people for the first time. **You may be eligible if...** - You are an adult with a confirmed advanced, recurrent, or metastatic solid tumor - Your cancer has progressed after at least one standard treatment, or standard treatment is not suitable for you - You have at least one measurable tumor - You are in relatively good physical condition (ECOG status 0 or 1 — fully active or able to do light activity) - Your expected life expectancy is at least 3 months - Your heart function is adequate **You may NOT be eligible if...** - Your cancer has spread to the brain and is untreated - You have significant organ dysfunction or unstable health conditions Talk to your doctor to see if this trial is right for you.

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.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

BIOLOGICALBNT3212

Intravenous infusion

BIOLOGICALPumitamig

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

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT07147348


Related Trials