OncoMatch/Clinical Trials/NCT07288359
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
Is NCT07288359 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies multiple treatments including GVV858 and Fulvestrant for advanced hr+/her2- breast cancer.
Treatment: GVV858 · Fulvestrant · Letrozole — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Breast Carcinoma
Tumor Agnostic
Prostate Cancer
Biomarker criteria
Required: ESR1 hormone receptor-positive
HR+
Required: HER2 (ERBB2) HER2-negative
HER2-
Required: CCNE1 amplification
CCNE1 amplification
Disease stage
Required: Stage III, IV
advanced; locally advanced or metastatic; measurable disease as determined by RECIST v1.1
Prior therapy
Must have received: hormone-based therapy — advanced/metastatic
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
Must have received: CDK4/6 inhibitor — advanced/metastatic
disease progression on or following at least one line of hormone-based therapy in combination with a CDK4/6i
Cannot have received: cytotoxic chemotherapy
Exception: Phase II HR+/HER2- aBC only; no prior cytotoxic chemotherapy or antibody-drug-conjugate for advanced disease
no prior cytotoxic chemotherapy or antibody-drug-conjugate for advanced disease
Cannot have received: antibody-drug conjugate
Exception: Phase II HR+/HER2- aBC only; no prior cytotoxic chemotherapy or antibody-drug-conjugate for advanced disease
no prior cytotoxic chemotherapy or antibody-drug-conjugate for advanced disease
Lab requirements
Blood counts
adequate bone marrow function required; out-of-range laboratory values excluded
Kidney function
adequate organ function required; out-of-range laboratory values excluded
Liver function
adequate organ function required; out-of-range laboratory values excluded
Cardiac function
clinically significant, uncontrolled heart disease and/or cardiac repolarization abnormality including MI, CABG, long QT syndrome, or risk factors for Torsades de Pointes (TdP) excluded
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).
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Tennessee Oncology PLLC · Nashville, Tennessee
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