GVV858 alone or with hormone therapy for advanced breast cancer and other solid tumors

Trial details

Who runs it

Novartis Pharmaceuticals

Trial code

NCT07288359

Record updated

29 October 2026

Original description

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.Read full original descriptionShow less

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

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.

Inclusion: 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 (mCRPC), with no documented neuroendocrine component, castrate level of testosterone. For dose expansion only: 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; 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.

Exclusion: 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; For patients with BC: Patient is concurrently using hormone replacement therapy; 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); Patients with visceral crisis; 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.

ClinicalTrials.gov NCT07288359