Study on GVV858 Alone or with Hormone Therapy for HR+/HER2- Breast Cancer and Other Advanced Tumors

Sponsor: Novartis Pharmaceuticals

Sponsor score: 60

ClinicalTrials ID:NCT07288359

Provider View

This clinical trial is testing a new drug, GVV858, alone or with hormone therapy, to see if it is safe and effective for patients with HR+/HER2- breast cancer and other advanced solid tumors.

Patient Parameters

Program Overview

The study is divided into two phases. Phase I aims to find out how safe and tolerable GVV858 is when used alone or with hormone therapies like fulvestrant or letrozole. It will also help determine the best dose for future studies. Phase II will further explore the safety and effectiveness of GVV858 combined with fulvestrant in patients with advanced HR+/HER2- breast cancer.

Description

This is a first-time study in humans to test GVV858, a new drug, for treating advanced HR+/HER2- breast cancer and other advanced solid tumors. The study has two parts: one where GVV858 is given alone to patients with certain advanced cancers, and another where it is combined with hormone therapies like fulvestrant or letrozole for patients with advanced HR+/HER2- breast cancer. The study will start by testing different doses to find the safest and most effective one. If successful, the study will expand to include more patients to better understand how well the treatment works.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Have one of the following advanced cancers confirmed by lab tests:
    • HR+/HER2- advanced breast cancer that has worsened after at least one hormone therapy combined with a CDK4/6 inhibitor and one other treatment for metastatic disease.
    • Locally advanced or metastatic cancer with a specific gene change (CCNE1 amplification), with no more than three previous treatments for advanced disease.
    • Metastatic castration-resistant prostate cancer with no neuroendocrine component, low testosterone levels, and no more than three previous treatments for metastatic disease.
  • For Phase II: HR+/HER2- advanced breast cancer that has worsened after hormone therapy combined with a CDK4/6 inhibitor, with no more than two hormone therapies and no prior chemotherapy for advanced disease.
  • Must have measurable disease or specific bone lesions that can be assessed.

Exclusion Criteria

  • Poor bone marrow or organ function based on lab tests.
  • Uncontrolled heart disease or heart rhythm problems.
  • Active brain metastases needing treatment or increasing steroid doses.
  • Severe symptoms from cancer affecting organs.
  • For breast cancer patients: currently using hormone replacement therapy.
  • Women who can become pregnant must use effective birth control, and pregnant or nursing women cannot participate.
  • Other specific criteria may apply.

Locations

FACILITYZIPCITYSTATE
Tennessee Oncology PLLC37203NashvilleTennessee

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