Clinical Trial

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

Recruiting Phase 1/2
View on ClinicalTrials.gov →
Summary
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.
Protocol Amendment History 14 amendments
This ClinicalTrials.gov record has been amended 14 times since 2025-12-15; most recent amendment 2026-07-06.
Status change: Not Yet Recruiting → Recruiting 2025-12-19
Trial Details
NCT Number NCT07288359
Lead Sponsor Novartis Pharmaceuticals
Conditions Advanced HR+/HER2- Breast Cancer, Advanced CCNE1-amplified Solid Tumors, Metastatic Castration-resistant Prostate Cancer
Enrollment 205 participants
Start Date 2025-12-29
Primary Completion 2031-05-09 (estimated)
Study Completion 2031-05-09 (estimated)
Updated on ClinicalTrials.gov 2026-07-30