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New drug combo shows promise for Hard-to-Treat breast cancer

NCT ID NCT07288359

Disease control Sponsor: Novartis Pharmaceuticals Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jul 31, 2026 · Updated 7 times

Summary

This study tests a new drug called GVV858, alone or with hormone therapy, in people with advanced hormone receptor-positive, HER2-negative breast cancer and other solid tumors. The goal is to find the safest dose and see how well it works. About 205 adults whose cancer has progressed after standard treatments will take part.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 205 people

The number the study aims to enrol. It can still change while the study runs.

Started

Dec 2025

Expected to finish

May 2031

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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, with no documented neuroendocrine component, castrate level of testosterone, and 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. * 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 Criteria: * 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. Other protocol-defined inclusion/exclusion criteria may apply.

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Conditions

The condition(s) this trial relates to.

breast neoplasm castration-resistant prostate carcinoma hormone receptor-positive breast cancer metastatic prostate carcinoma prostate cancer

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Advanced CCNE1-amplified solid tumors Advanced HR+/HER2- breast cancer Metastatic castration resistant prostate cancer

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    15 sites in 10 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Emory University

    RECRUITING

    Atlanta, Georgia, 30322, United States

  • Novartis Investigative Site

    RECRUITING

    Olomouc, 779 00, Czechia

  • Novartis Investigative Site

    RECRUITING

    Odense C, 5000, Denmark

  • Novartis Investigative Site

    RECRUITING

    Pierre-Bénite, 69495, France

  • Novartis Investigative Site

    RECRUITING

    Jena, Thuringia, 07740, Germany

  • Novartis Investigative Site

    RECRUITING

    Essen, 45147, Germany

  • Novartis Investigative Site

    RECRUITING

    Milan, MI, 20141, Italy

  • Novartis Investigative Site

    RECRUITING

    Milan, MI, 20162, Italy

  • Novartis Investigative Site

    RECRUITING

    Kyoto, 6068507, Japan

  • Novartis Investigative Site

    RECRUITING

    Singapore, 168583, Singapore

  • Novartis Investigative Site

    RECRUITING

    Barcelona, 08035, Spain

  • Novartis Investigative Site

    RECRUITING

    Madrid, 28041, Spain

  • Novartis Investigative Site

    RECRUITING

    Taipei, 10002, Taiwan

  • START

    RECRUITING

    San Antonio, Texas, 78229, United States

  • Tennessee Oncology PLLC

    RECRUITING

    Nashville, Tennessee, 37203, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.