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Study identifier: NCT07288359 Synced from ClinicalTrials.gov · July 28, 2026
● Recruiting

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

Condition: Advanced HR+/HER2- Breast Cancer · Advanced CCNE1-amplified Solid Tumors · Metastatic Castration-resistant Prostate Cancer  ·  Sponsor: Novartis Pharmaceuticals

PhasePhase 1/Phase 2
Planned participants205
Who can joinAll sexes, 18 Years to no upper limit
Healthy volunteersNo

About this study

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.

This description comes directly from the study's public registry record.

Talk to the study team

Novartis Pharmaceuticals  ·  1-888-669-6682  ·  novartis.email@novartis.com

Novartis Pharmaceuticals  ·  +41613241111

Always discuss trial participation with your own doctor first.

Locations (14)

Tennessee Oncology PLLCNashville, Tennessee, United StatesRecruiting
STARTSan Antonio, Texas, United StatesRecruiting
Novartis Investigative SiteOlomouc, CzechiaRecruiting
Novartis Investigative SiteOdense C, DenmarkRecruiting
Novartis Investigative SitePierre-Bénite, FranceRecruiting
Novartis Investigative SiteJena, Thuringia, GermanyRecruiting
Novartis Investigative SiteEssen, GermanyRecruiting
Novartis Investigative SiteMilan, MI, ItalyRecruiting
Novartis Investigative SiteMilan, ItalyRecruiting
Novartis Investigative SiteKyoto, JapanRecruiting
Novartis Investigative SiteSingapore, SingaporeRecruiting
Novartis Investigative SiteBarcelona, SpainRecruiting

+ 2 more locations — full list on the registry record.

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Source record: clinicaltrials.gov/study/NCT07288359