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GVV858

Clinical trials are investigating GVV858 in people with advanced HR+/HER2- breast cancer and other advanced solid tumors. These studies look at safety, tolerability, and the best dose range, and they also test GVV858 alone or with endocrine therapy. The main phase is Phase 1/2.

Table of Contents

Trial overview

The study of GVV858 is an interventional study, which means researchers give a treatment and then observe the results.[1] It is authorised and planned to enroll 85 people.[1]

The trial title says it is studying GVV858 as a single agent or in combination with endocrine therapy in patients with HR+/HER2- breast cancer and other advanced solid tumors.[1]

Who the study is for

The main condition listed in the trial data is advanced HR+/HER2- breast cancer.[1] HR+/HER2- means the cancer has hormone receptors and does not have high HER2 levels, which helps define the cancer type.[1]

The title also mentions other advanced solid tumors, so the study is not limited only to breast cancer in its wording.[1] However, the condition field specifically highlights advanced HR+/HER- breast cancer.[1]

What is being tested

GVV858 is being tested as a single agent, which means by itself, and also in combination with endocrine therapy.[1] Endocrine therapy is treatment that changes hormone signals that can help some cancers grow.[1]

The trial data lists combination partners including fulvestrant and letrozole, and it also lists hormone-lowering medicines such as goserelin and leuprorelin acetate.[1] The brief summary says Phase I will assess GVV858 as a single agent and in combination with fulvestrant or letrozole.[1]

Study phase and goals

This is a Phase 1/2 trial, which is an early stage of clinical research.[1] Phase 1 usually focuses on safety and dose finding, while Phase 2 looks more closely at safety and tolerability in a larger group.[1]

The brief summary says Phase I aims to assess safety and tolerability and to identify the recommended dose or dose range for further clinical evaluation.[1] Phase II aims to further characterize the safety and tolerability of GVV858 in combination with fulvestrant.[1]

What researchers measure

The main outcomes in Phase I include dose-limiting toxicities, adverse events, serious adverse events, and changes in lab values, vital signs, and electrocardiograms (ECGs).[1] Dose-limiting toxicities are side effects that are serious enough to limit how much treatment can be given.[1]

The study also measures tolerability by tracking dose interruptions, dose reductions, discontinuations, and dose intensity.[1] In Phase II, the study continues to measure safety and tolerability using the same types of checks, including adverse events, serious adverse events, lab values, vital signs, and ECGs.[1]

These outcomes help researchers understand whether GVV858 can be given safely and how well people can stay on treatment.[1]

Trial ID Phase Condition studied Status Enrollment
2025-521911-38-00 Phase 1/2 Advanced HR+/HER2- breast cancer and other advanced solid tumors Authorised 85

FAQ

  • What are the GVV858 trials studying? The trials are studying GVV858 as a single treatment and in combination with endocrine therapy. They focus on safety, tolerability, and finding the recommended dose or dose range.
  • Who can join the GVV858 study? The main target group is people with advanced HR+/HER2- breast cancer. The study also includes other advanced solid tumors in the title, but the trial data mainly highlights breast cancer.
  • What phase are the GVV858 trials? This is a Phase 1/2 study. Phase 1 looks at safety and dose finding, and Phase 2 looks more closely at safety and tolerability in a larger group.
  • What treatments are compared or combined with GVV858? GVV858 is studied alone and with endocrine therapy such as fulvestrant or letrozole. The trial data also lists hormone-lowering medicines like goserelin and leuprorelin acetate.
  • What results are the researchers measuring? The main results are dose-limiting toxicities, side effects, serious side effects, and changes in lab tests, vital signs, and ECGs. The study also tracks dose interruptions, dose reductions, and treatment stops.

Ongoing Clinical Trials on GVV858

  • A Phase I/II Study of GVV858 Alone or in Drug Combination for Patients with Advanced Hormone Receptor‑Positive, HER2‑Negative Breast Cancer

    Recruiting

    2 1 1 1
    Investigated diseases:
    Investigated drugs:
    Czechia Denmark France Germany Italy Spain

Glossary

  • Advanced cancer: Cancer that has grown beyond the original site or is not easily treated with standard local treatment.
  • HR+/HER2-: A breast cancer type that has hormone receptors (HR) and does not have high HER2 levels. This helps doctors choose treatments.
  • Solid tumor: A lump or mass of cancer cells in an organ or tissue, such as breast cancer.
  • Interventional study: A clinical trial where researchers give a treatment and then watch what happens.
  • Phase 1/2: An early stage of research. Phase 1 checks safety and dose, and Phase 2 looks more closely at safety and early activity.
  • Safety: How well a treatment can be used without causing too much harm.
  • Tolerability: How well people can handle a treatment and its side effects.
  • Dose-limiting toxicities (DLTs): Side effects that are serious enough to limit how much of a treatment can be given.
  • Adverse events (AEs): Any unwanted medical problem that happens during a study.
  • Serious adverse events (SAEs): Unwanted medical problems that are severe or may be life-threatening.
  • Electrocardiogram (ECG): A test that checks the heart’s electrical activity.
  • Endocrine therapy: Treatment that works by changing hormone signals that can help some cancers grow.

References

  1. https://clinicaltrials.gov/study/2025-521911-38-00