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)
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
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: Emory University — Atlanta, Georgia
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (15 Sites)
- Emory University — Atlanta, Georgia
- Tennessee Oncology PLLC — Nashville, Tennessee
- START — San Antonio, Texas
- Novartis Investigative Site — Olomouc,
- Novartis Investigative Site — Odense C,
- Novartis Investigative Site — Pierre-Bénite,
- Novartis Investigative Site — Jena, Thuringia
- Novartis Investigative Site — Essen,
- Novartis Investigative Site — Milan, MI
- Novartis Investigative Site — Milan, MI
- Novartis Investigative Site — Kyoto,
- Novartis Investigative Site — Singapore,
- Novartis Investigative Site — Barcelona,
- Novartis Investigative Site — Madrid,
- Novartis Investigative Site — Taipei,
📞 Contact the Study Coordinator
Phone: (888) 669-6682
Email: novartis.email@novartis.com
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
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💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.