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NCT07288359 · ClinicalTrials.gov registry record · 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

A Phase 1 study of Metastatic Castration-Resistant Prostate Cancer and Advanced HR+/HER2- Breast Cancer, sponsored by Novartis Pharmaceuticals.

Recruiting
Registry status
Phase 1
Development phase
205
Enrollment target
4
Study locations

NCT07288359 is a Phase 1 study of Metastatic Castration-Resistant Prostate Cancer and Advanced HR+/HER2- Breast Cancer that is actively recruiting participants, run by Novartis Pharmaceuticals. The registered enrollment target is 205 participants, roughly in line with the 195-participant average among 69 other Metastatic Castration-Resistant Prostate Cancer trials with a reported enrollment target. The trial reports 4 study locations across 2 states.

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The verdict

NCT07288359, a Phase 1 study of Metastatic Castration-Resistant Prostate Cancer and Advanced HR+/HER2- Breast Cancer, is actively recruiting participants, sponsored by Novartis Pharmaceuticals.

RECRUITING
Registry status
Phase 1
Development phase
205 participants
Enrollment target
4
Study locations

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.

Conditions Studied

Metastatic Castration-Resistant Prostate Cancer Advanced HR+/HER2- Breast Cancer Advanced CCNE1-amplified Solid Tumors

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

1,375 total trials

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What the Registry Record Tells You About NCT07288359

The ClinicalTrials.gov registry entry for NCT07288359 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 205 participants, a figure that helps gauge the scale of data the investigators plan to collect, roughly in line with the 195-participant average among 69 other Metastatic Castration-Resistant Prostate Cancer trials with a reported enrollment target. The listed sponsor is Novartis Pharmaceuticals, which has 1,375 total studies on file at ClinicalTrials.gov.

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.

NCT07288359 reports 4 study locations spanning 2 distinct geographic areas - top geographies include Other, Tennessee.

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.

What interventions are being tested in trial NCT07288359?

The interventions under investigation include: Letrozole (DRUG), Fulvestrant (DRUG), GVV858 (DRUG).

Who is sponsoring clinical trial NCT07288359?

This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.

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.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.