MedTrace Logo

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

NCT07455734 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 533

Last updated 2026-05-14

No results posted yet for this study

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.

Conditions

  • Advanced Solid Tumor Cancer

Interventions

DRUG

BNT3214

Intravenous infusion

Sponsors & Collaborators

  • BioNTech (Shanghai) Pharmaceuticals Co., Ltd.

    collaborator INDUSTRY

  • Biotheus (Hengqin) Co., Ltd.

    collaborator UNKNOWN

  • BioNTech SE

    lead INDUSTRY

Principal Investigators

  • BioNTech Responsible Person · BioNTech SE

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-03-30
Primary Completion
2030-10-31
Completion
2030-10-31

Countries

  • Australia
  • China
  • Taiwan

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07455734 on ClinicalTrials.gov