drugset / Trial / NCT05954143

Trial of BDC-1001 +/- Pertuzumab in Subjects With HER2-Positive Metastatic Breast Cancer

NCT05954143 ↗

RandomizedParallel-groupOpen-labelTreatment

Summary

This is an open-label, Phase 2 study to evaluate preliminary anti-tumor activity, safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and immunogenicity of BDC-1001 administered as a single agent and in combination with pertuzumab in subjects with human epidermal growth factor receptor 2-positive (HER2+) metastatic breast cancer (MBC) previously treated with trastuzumab deruxtecan (Enhertu®).

Timeline

Start
2023-11-30
Primary completion
2024-09-20
Completion
2024-09-25

Outcome

Outcome not reported

Stopped (Business): “Sponsor Decision”

Drugs

EvaluationDrugModalityDoseRoute
Subject Pertuzumab Monoclonal antibody 420 mg Intravenous
Subject TRASTUZUMAB IMBOTOLIMOD Monoclonal antibody — Intravenous