Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

RECRUITING Phase 1

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

NCT07288359 · View on ClinicalTrials.gov ↗

Study 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.

Interventions

  • DRUG Letrozole
  • DRUG Fulvestrant
  • DRUG GVV858

Study Locations (4)

Other

  • Novartis Investigative Site — Kyoto
  • Novartis Investigative Site — Singapore
  • Novartis Investigative Site — Taipei

Tennessee

  • Tennessee Oncology PLLC — Nashville

Trial Details

FieldValue
Enrollment Target 205 participants
Start Date 2025-12-29
Est. Completion 2031-05-09
Phase Phase 1

Sponsor

Novartis Pharmaceuticals

792 total trials

Interested in This Trial?

Always speak with your doctor before enrolling in a clinical trial.

Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT07288359

The ClinicalTrials.gov registry entry for NCT07288359 describes a study currently listed as recruiting. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 205 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Novartis Pharmaceuticals, which has 792 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 3 conditions, with Metastatic Castration-resistant Prostate Cancer appearing as the primary indexed condition, and to 3 interventions — of which Letrozole is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT07288359 reports 4 study locations spanning 2 distinct geographic areas — top geographies include Other, Tennessee. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT07288359 about?

NCT07288359 is a clinical study titled "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". 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...

What is the current status of trial NCT07288359?

This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 205 participants. The study started on 2025-12-29. Estimated completion is 2031-05-09.

What conditions does trial NCT07288359 study?

This clinical trial studies the following conditions: Metastatic Castration-resistant Prostate Cancer, Advanced HR+/HER2- Breast Cancer, Advanced CCNE1-amplified Solid Tumors. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT07288359?

The interventions under investigation include: Letrozole (DRUG), Fulvestrant (DRUG), GVV858 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT07288359?

This trial is sponsored by Novartis Pharmaceuticals, which has 792 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT07288359 being conducted?

This trial has 4 study locations across Tennessee. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial