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RECRUITINGPhase 1/2

Study of GVV858 as a Single Agent or in Combination With Endocrine Therapy in Patients With HR+/HER2- Breast Cancer and Other Advanced Solid Tumors

NCT07288359

Phase I: Characterize safety and tolerability of GVV858 as a single agent and in combination with fulvestrant or letrozole. Identify dose range for optimization/recommended dose for further clinical evaluation. Phase II: Further characterize the safety and tolerability of GVV858 in combination with fulvestrant in patients with hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR+/HER2-) advanced breast cancer.

Advanced HR+/HER2- Breast CancerAdvanced CCNE1-amplified Solid TumorsMetastatic Castration-resistant Prostate Cancer

Novartis Pharmaceuticals205 participantsStarted Dec 2025

Nashville, Tennessee, United States • Odense C, Denmark • Jena, Thuringia, Germany +8 more locations

Data from ClinicalTrials.govTerms