RecruitingPhase 1Phase 2NCT07288359

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

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


Sponsor

Novartis Pharmaceuticals

Enrollment

205 participants

Start Date

Dec 29, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This early-phase trial is testing a new drug called GVV858 — alone and combined with hormone therapy — in people with HR+/HER2-negative advanced breast cancer and other solid tumors with certain genetic changes. **You may be eligible if...** - You are 18 or older - You have HR+/HER2-negative advanced breast cancer that has progressed on at least one hormone-based therapy combined with a CDK4/6 inhibitor, plus at least one additional treatment line - Or you have another advanced cancer with a CCNE1 gene amplification (Phase I) - Or you have metastatic castration-resistant prostate cancer - No further standard therapy is available or appropriate for your disease **You may NOT be eligible if...** - You have not yet tried required prior therapies - You have received more than 3 prior treatment lines for metastatic disease (for expansion cohorts) - You have serious organ dysfunction or active brain metastases - You have neuroendocrine features in your prostate cancer Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGGVV858

Experimental

DRUGFulvestrant

Approved medication

DRUGLetrozole

Approved medication


Locations(4)

Tennessee Oncology PLLC

Nashville, Tennessee, United States

Novartis Investigative Site

Kyoto, Japan

Novartis Investigative Site

Singapore, Singapore

Novartis Investigative Site

Taipei, Taiwan

View Full Details on ClinicalTrials.gov

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NCT07288359


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