drugset / Trial / NCT06449222

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

NCT06449222

Phase 2 Active not recruiting 83 enrolled BioNTech SE Bristol-Myers Squibb · collab
RandomizedParallel-groupOpen-labelTreatment

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).

Timeline

Start
2024-08-26
Primary completion
2028-08
Completion
2029-06

Drugs

EvaluationDrugModalityDoseRoute
Subject Carboplatin Small molecule Intravenous
Subject Eribulin Small molecule Intravenous
Subject Gemcitabine Small molecule Intravenous
Subject Nab-placlitaxel Unknown Intravenous
Subject Paclitaxel Small molecule Intravenous
Subject Pumitamig Protein / enzyme biologic Intravenous