Study of GVV858 as a Single Agent or in Combination With Endocrine Therapy in Patients With HR+/H… (NCT07288359) | Clinical Trial Compass
RecruitingPhase 1/2
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
United States, Denmark, Germany205 participantsStarted 2025-12-29
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since this trial is in Phase 1/Phase 2 and is still figuring out the right dose of GVV858, what does that mean for my safety, and how closely would I be monitored for serious side effects like dose-limiting toxicities?
2My cancer is HR+/HER2- breast cancer — would I be taking GVV858 alone or combined with endocrine therapy, and how would that decision be made for my specific situation?
3The trial is tracking how often patients need dose interruptions or reductions, which suggests side effects may require adjustments — based on what's known so far, what kinds of side effects should I be prepared for with GVV858?
4Given that this is an early-phase trial focused primarily on safety rather than proven benefit, would standard treatments or other approved options be a better first step for me before considering something like this?
5My tumor would need to fit specific criteria — either HR+/HER2- breast cancer, CCNE1-amplified solid tumors, or castration-resistant prostate cancer — how would my doctor confirm which category I fall into and whether that makes me a potential candidate worth discussing with the trial team?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Phase I: Incidence and severity of dose-limiting toxicities (DLTs)
Timeframe: 28 days
2
Phase I and phase II: Incidence and severity of adverse events (AEs) and serious adverse events (SAEs)
Timeframe: Up to approximately 2 years
3
Phase I and phase II: Frequency of dose interruptions, reductions and discontinuations