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Safety and Preliminary Effectiveness of BNT327, an Investigational Therapy for Breast Cancer, When Given in Combination With Chemotherapy

NCT06449222 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 83

Last updated 2026-02-25

No results posted yet for this study

Summary

This study is a Phase II, multi-site, randomized, open-label clinical study to evaluate the safety, efficacy, and pharmacokinetics (PK) of BNT327 at two dose levels in combination with chemotherapeutic agents in the first- and second-line treatment of participants with locally advanced/metastatic triple-negative breast cancer (mTNBC).

Conditions

Interventions

DRUG

BNT327 Dose Level 1 (DL1)

Intravenous (IV) infusion

DRUG

BNT327 Dose Level 1 (DL2)

IV infusion

DRUG

Nab-placlitaxel

IV infusion

DRUG

Carboplatin

IV infusion

DRUG

Gemcitabine

IV infusion

DRUG

Paclitaxel

IV infusion

DRUG

Eribulin

IV infusion

DRUG

BNT327 Optimized Dose

IV infusion

DRUG

BNT327 Equivalent Q3W Dose

IV infusion

Sponsors & Collaborators

Principal Investigators

  • BioNTech Responsible Person · BioNTech SE

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-08-26
Primary Completion
2028-08-31
Completion
2029-06-30
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Turkey (Türkiye)
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Diseases
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 NCT06449222 on ClinicalTrials.gov