Back to search results

Study of GVV858 for Advanced Breast Cancer and Other Solid Tumors

This study is testing an experimental drug called GVV858, either by itself or with approved medications like fulvestrant or letrozole. It's for people aged 18 and older with advanced hormone receptor-positive/HER2-negative (HR+/HER2-) breast cancer, other advanced solid tumors with a specific genetic change called CCNE1 amplification, or metastatic prostate cancer that has stopped responding to hormone therapy. The main goals are to understand the safety and side effects of GVV858, and to find the best dose. The study aims to enroll 205 participants. The current recruitment status is unclear.

Study design
This is an open-label, multi-center study, meaning you and your doctors will know which treatment you are receiving. It includes different groups, some receiving GVV858 alone and others receiving it with fulvestrant or letrozole.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Your safety and side effects will be monitored for up to approximately 2 years.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

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

Recruiting
PHASE1Ages 18+InterventionalTreatment
Novartis Pharmaceuticals
~205 participants
Updated 2026-07-30 on ClinicalTrials.gov
What's tested:GVV858FulvestrantLetrozole

At a glance

Recruiting sites
15 of 15 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Phase I: Incidence and severity of dose-limiting toxicities (DLTs)
Measured over 28 days
+3 more outcomes measured

Conditions

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

Explore related trials

Breast CarcinomaProstate CarcinomaSolid Neoplasm

Where it's being run

15 sites across 13 states
MI2
Spain2
Georgia1
Tennessee1
Texas1
Czechia1
Denmark1
France1

Who to contact

Novartis Pharmaceuticals
[email protected]
1-888-669-6682
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Inclusion

Age ≥ 18 years old.
Patients with one of the following histologically or cytologically confirmed advanced cancers:
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.
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.
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.

Exclusion

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.

What this trial measures

  • Phase I: Incidence and severity of dose-limiting toxicities (DLTs)28 days

    Number of participants with DLTs. A DLT is defined as an adverse event or abnormal laboratory value of Common Terminology Criteria for Adverse Events (CTCAE) grade 3 or higher, unless clearly and inconvertibly assessed as due to disease progression, inter-current illness/injury, concomitant medications, or extraneous causes, that occurs within the first 28 days of treatment in the Phase 1 part. Other clinically significant toxicities may be considered to be DLTs, even if not CTCAE grade 3 or higher.

  • Phase I and phase II: Incidence and severity of adverse events (AEs) and serious adverse events (SAEs)Up to approximately 2 years

    Number of participants with AEs and SAEs, including changes in vital signs, electrocardiograms (ECGs) and laboratory values qualifying and reported as AEs.

  • Phase I and phase II: Frequency of dose interruptions, reductions and discontinuationsUp to approximately 2 years

    Number of participants with dose adjustments (reductions, interruption, or permanent discontinuation) as a measure of tolerability.

  • Phase I and phase II: Dose intensityUp to approximately 2 years

    The dose intensity of each study drug is computed as the ratio of actual cumulative dose received and actual duration of exposure.