NCT04826016

POL6326 (Balixafortide) Plus Nab-paclitaxel or Eribulin in Patients With HER2-negative Advanced Breast Cancer

A Phase Ib/II Study to Optimize POL6326 (Balixafortide) in Combination With Nab-paclitaxel or Eribulin in Patients With HER2-negative Advanced Breast Cancer

• Status: Withdrawn
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: MedSIR · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a multicenter Phase Ib/II, open-label, dose-escalation study to optimize POL6326 (balixafortide) in combination with nab-paclitaxel or eribulin in patients with HER2-negative advanced breast cancer.

Conditions

• Advanced Breast Cancer

Interventions

Type	Name	Description
DRUG	POL6326	POL6326 (balixafortide): starting dose at 5.5 mg/Kg. Intravenous administration on day 1 and 8 of each 21-day cycle (+/- 1 day) (Phase Ib ARM A and Phase II ARM A ) or on day 1, 8 and 15 of each 28-day cycle (Phase Ib ARM B and Phase 2 ARM B) (+/- 1 day).
DRUG	Eribulin	Eribulin: 1.23 mg/m2 (equivalent to 1.4 mg/m2 eribulin mesylate). Intravenous administration on day 1 and 8 of each 21-day cycle (+/- 1 day) (Phase Ib ARM A and Phase II ARM A ) or on day 1, 8 and 15 of each 28-day cycle (Phase Ib ARM B and Phase 2 ARM B) (+/- 1 day).
DRUG	Nab paclitaxel	Nab-paclitaxel: 100 mg/m2. Intravenous administration on day 1 and 8 of each 21-day cycle (+/- 1 day) (Phase Ib ARM A and Phase II ARM A) or on day 1, 8 and 15 of each 28-day cycle (Phase Ib ARM B and Phase 2 ARM B) (+/- 1 day).

Timeline

• Start date: 2022-03-16
• Primary completion: 2022-03-16
• Completion: 2022-03-16
• First posted: 2021-04-01
• Last updated: 2023-03-20