An Open-label, Multi-center, Phase I/II Study of GVV858 as a Single Agent and in Combination With Endocrine Therapy in Patients With Advanced Hormone Receptor Positive, HER2- Negative Breast Cancer and Other Advanced Solid Tumors
This study is testing a new experimental drug called GVV858, both on its own and combined with standard hormone-blocking therapies. Researchers want to see if this combination can safely and effectively treat specific types of advanced breast, prostate, and solid tumor cancers.
This trial is for adults (18+) with advanced cancers that have continued to grow after previous treatments. You must have a specific genetic marker (CCNE1 amplification) or meet certain breast or prostate cancer criteria to be eligible.
You will receive the study drug GVV858, sometimes alongside common hormone treatments like fulvestrant or letrozole. The medical team will closely monitor your health, bloodwork, and how your body responds to the treatment throughout the study.
The study is currently recruiting patients at medical centers in Nashville (Tennessee), San Antonio (Texas), and Olomouc (Czechia).
- 1The study tests a new drug, GVV858, to find the safest and most effective dose.
- 2Participants must have advanced cancer and meet specific medical history requirements.
- 3People with certain heart conditions or untreated brain/spinal cord cancer cannot participate.
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