drugset / Trial / NCT02776917

Study of Cirmtuzumab and Paclitaxel for Metastatic or Locally Advanced, Unresectable Breast Cancer

NCT02776917

NaSingle-groupOpen-labelTreatment

Summary

This is a pilot phase 1b study to investigate the safety and side effects of combining the ROR1-targeting monoclonal antibody, cirmtuzumab, with paclitaxel for patients with HER2 negative, metastatic breast cancer. Cirmtuzumab is a type of drug called a monoclonal antibody. This drug is designed to attach to a protein called receptor-tyrosine-kinase like orphan receptor 1 (ROR1) on the surface of breast cancer cells. Cirmtuzumab blocks the growth and survival of the breast cancer cells in laboratory tests. ROR1 is rarely expressed on healthy cells. Cirmtuzumab is considered experimental and is not approved by United States (U.S.) Food and Drug Administration (FDA).

Timeline

Start
2018-08-15
Primary completion
2021-07-13
Completion
2024-02-26

Drugs

EvaluationDrugModalityDoseRoute
Subject Cirmtuzumab Monoclonal antibody 600 mg Intravenous
Subject Paclitaxel Small molecule 80 mg/m2 Intravenous

Indications