NCT06374459

Zunsemetinib in Combination With Capecitabine in Patients With Hormone Receptor-Positive and HER2-Negative Metastatic Breast Cancer With Bone Metastasis

A Phase Ib/II Trial of Zunsemetinib in Combination With Capecitabine in Patients With Hormone Receptor-Positive and HER2-Negative Metastatic Breast Cancer With Bone Metastasis

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 152 (estimated)
• Sponsor: Washington University School of Medicine · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a phase Ib/II study evaluating the safety and efficacy of zunsemetinib (ATI-450) with capecitabine in patients with hormone receptor-positive and HER2-negative (HR+/HER2-) metastatic breast cancer (MBC).

Conditions

• Hormone Receptor Positive HER-2 Negative Metastatic Breast Cancer

Interventions

Type	Name	Description
DRUG	Zumsemetinib	Patients should take zunsemetinib at approximately the same times every day, with or without food with 8 oz of water.
DRUG	Capecitabine	Patients should take capecitabine at approximately the same times every day, within 30 minutes after a meal.
DRUG	Zoledronic acid	Standard of care. Will receive zoledronic acid or denosumab.
DRUG	Denosumab	Standard of care. Will receive zoledronic acid or denosumab.

Timeline

• Start date: 2025-01-30
• Primary completion: 2032-05-31
• Completion: 2032-05-31
• First posted: 2024-04-18
• Last updated: 2026-02-09

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study