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 now · Phase 1/Phase 2

Conditions studied: Advanced HR+/HER2- Breast Cancer, Advanced CCNE1-amplified Solid Tumors, Metastatic Castration-resistant Prostate Cancer

In brief

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.

Key facts

Study ID

NCT07288359

Run by

Novartis Pharmaceuticals

People needed

205

Starts

2025-12-29

Expected to finish

2031-05-09

Last updated by the study team

2026-07-30

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age ≥ 18 years old.
• Patients with one of the following histologically or cytologically confirmed advanced cancers:
• Phase I (patients with one of the following cancers, from whom no standard therapy is available or appropriate in the judgment of the investigator):
• HR+/HER2- advanced breast cancer (aBC) with disease progression on or following at least one line of hormone-based therapy in combination with a CDK4/6i and at least one additional line of systemic therapy for metastatic disease.
• Locally advanced or metastatic cancer with a CCNE1 amplification. For dose expansion only: no more than 3 prior lines of therapy for advanced or metastatic disease.
• Metastatic castration-resistant prostate adenocarcinoma, with no documented neuroendocrine component, castrate level of testosterone, and no more than 3 prior lines of systemic therapy for metastatic disease.
• Phase II:
• HR+/HER2- aBC with disease progression on or after an endocrine therapy in combination, with a CDK4/6 inhibitor for advanced disease with no more than 2 lines of endocrine therapy and no prior cytotoxic chemotherapy or antibody-drug-conjugate for advanced disease.
• Measurable disease as determined by RECIST v1.1.
• BC only: If no measurable disease is present, then at least one predominantly lytic bone lesion must be present that can be accurately assessed at baseline and is suitable for repeated assessment.
• metastatic Castration-Resistant Prostate Cancer (mCRPC) only: If no measurable disease is present per PCWG3 modified RECIST, then at least 1 metastatic lesion must be present on bone scan imaging.

You may not qualify if…

• Patients with inadequate bone marrow and/or organ functions with out-of-range laboratory values.
• Clinically significant, uncontrolled heart disease and/or cardiac repolarization abnormality including myocardial infarction (MI), coronary artery bypass graft (CABG), long QT syndrome, or risk factors for Torsades de Pointes (TdP).
• Presence of symptomatic central nervous system (CNS) metastases or CNS metastases that require local therapy or increasing doses of corticosteroids within 2 weeks prior to study entry.
• Patients with symptomatic visceral disease, including visceral crisis.
• For patients with BC: Patient is concurrently using hormone replacement therapy.
• Women of childbearing potential who are unwilling to use highly effective contraception methods, pregnant or nursing women.
• Other protocol-defined inclusion/exclusion criteria may apply.

Where it is running

• Emory University — Atlanta, Georgia, United States (enrolling)
• Tennessee Oncology PLLC — Nashville, Tennessee, United States (enrolling)
• START — San Antonio, Texas, United States (enrolling)
• Novartis Investigative Site — Olomouc, Czechia (enrolling)
• Novartis Investigative Site — Odense C, Denmark (enrolling)
• Novartis Investigative Site — Pierre-Bénite, France (enrolling)
• Novartis Investigative Site — Jena, Thuringia, Germany (enrolling)
• Novartis Investigative Site — Essen, Germany (enrolling)
• Novartis Investigative Site — Milan, MI, Italy (enrolling)
• Novartis Investigative Site — Milan, MI, Italy (enrolling)
• Novartis Investigative Site — Kyoto, Japan (enrolling)
• Novartis Investigative Site — Singapore, Singapore (enrolling)
• Novartis Investigative Site — Barcelona, Spain (enrolling)
• Novartis Investigative Site — Madrid, Spain (enrolling)
• Novartis Investigative Site — Taipei, Taiwan (enrolling)

Full record on ClinicalTrials.gov

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