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RecruitingPhase 1 / Phase 2

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests the safety and doses of GVV858, used alone or with hormone therapy called fulvestrant or letrozole. It is for adults with certain advanced breast, prostate, or other solid cancers. The second part tests GVV858 with fulvestrant in advanced HR+/HER2- breast cancer, which uses hormones to grow and does not have high levels of HER2 protein.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You must be at least 18 years old and have an eligible advanced cancer confirmed by a tissue or cell test.
  • For Phase I, the study doctor must decide that no standard treatment is available or suitable for you.
  • Phase I breast cancer: You must have HR+/HER2- cancer that worsened during or after hormone therapy with a CDK4/6 inhibitor, a drug that slows cancer cell growth. You must also have had at least one other drug treatment for cancer that has spread.
  • Phase I other solid cancers: Your cancer must have grown into nearby areas or spread and have extra copies of the CCNE1 gene. For the dose expansion group, you may have had no more than 3 past treatment courses for advanced cancer.
  • Phase I prostate cancer: Your cancer must have spread and still grow despite very low testosterone levels. It must be adenocarcinoma, a gland-cell cancer, with no recorded neuroendocrine type. You may have had no more than 3 past drug treatment courses for cancer that has spread.
  • Phase II breast cancer: Your HR+/HER2- cancer must have worsened during or after hormone therapy with a CDK4/6 inhibitor for advanced cancer. You may have had no more than 2 hormone treatment courses and no chemotherapy or antibody-linked cancer drugs for advanced cancer.
  • Your cancer must be measurable using study rules. If it is not, breast cancer patients need at least one bone spot that mainly breaks down bone and can be checked repeatedly. Prostate cancer patients need at least one spot of cancer spread on a bone scan.

Who can't join

  • Blood tests show that your bone marrow or organs are not working well enough.
  • You have serious, uncontrolled heart disease or certain heart rhythm problems or risks, including the listed heart attack or heart bypass conditions.
  • Cancer in your brain or spinal cord causes symptoms, needs treatment directed at those spots, or requires increasing steroid doses within 2 weeks before joining.
  • Cancer in internal organs causes symptoms, including a severe threat to organ function.
  • You have breast cancer and are currently using hormone replacement therapy.
  • You are pregnant or breastfeeding, or you could become pregnant and are unwilling to use highly effective birth control.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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.

Study sites (3)

GA

TN

TX