Study to Evaluate the Safety and Antitumor Activity of CX-2009 Monotherapy and in Combination With CX-072 in Advanced Breast Cancer

Breast Cancer Clinical Trial

Official title: A Phase 2, Open-Label Study to Evaluate the Safety and Antitumor Activity of Praluzatamab Ravtansine (CX-2009) in Advanced HR-Positive/HER2-Negative Breast Cancer and of Praluzatamab Ravtansine as Monotherapy and in Combination With Pacmilimab (CX-072) in Advanced Triple-Negative Breast Cancer (CTMX-2009-002)

Status Completed

Clinical Trial Summary

A Phase 2, clinical study in advanced, metastatic breast cancer that will evaluate CX-2009 monotherapy in both Hormone Receptor(HR) positive/HER2 negative breast cancer and in TNBC, and evaluate CX-2009+CX-072 in TNBC

Clinical Trial Description

Eligible patients will be enrolled to the treatment arm based on breast cancer subtype.

Patients will receive study treatment on Day 1 of a Q3W cycle. Treatment with CX-2009 monotherapy (Arms A and B) or CX-2009 in combination with CX-072 (Arm C) will be given until disease progression or symptomatic deterioration, unacceptable toxicity necessitating treatment discontinuation, or if the patient meets certain study defined criteria for discontinuation. On-treatment tumor assessments, will occur every 6 weeks per RECIST v1.1 for the first 48 weeks, and every 12 weeks thereafter. ;

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Breast Neoplasms, Hormone Receptor Positive/HER2 Negative
• Breast Neoplasms, Triple-Negative
• Neoplasms
• Triple Negative Breast Neoplasms

• NCT number: NCT04596150
• Study type: Interventional
• Source: CytomX Therapeutics
• Status: Completed
• Phase: Phase 2
• Start date: December 29, 2020
• Completion date: June 2, 2023