drugset / Trial / NCT06374459
Zunsemetinib in Combination With Capecitabine in Patients With Hormone Receptor-Positive and HER2-Negative Metastatic Breast Cancer With Bone Metastasis
Phase 1/2
Recruiting
152 enrolled
Washington University School of Medicine
Aclaris Therapeutics, Inc. · collabUnited States Department of Defense · collab
RandomizedSequentialOpen-labelTreatment
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).
Timeline
- Start
- 2025-01-30
- Primary completion
- 2032-05-31
- Completion
- 2032-05-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Capecitabine | Small molecule | 1000 mg/m2 | Oral |
| Subject | Zunsemetinib | Small molecule | — | Oral |
| Comparator | Denosumab | Monoclonal antibody | — | — |
| Comparator | Zoledronic acid | Other / unclassified | — | — |