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

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. According to ClinicalTrials.gov, the official US trial registry.

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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.

Primary Outcome

Number of participants with DLTs. A DLT is defined as an adverse event or abnormal laboratory value of Common Terminology Criteria for Adverse Events (CTCAE) grade 3 or higher, unless clearly and inconvertibly assessed as due to disease progression, inter-current illness/injury, concomitant medications, or extraneous causes, that occurs within the first 28 days of treatment in the Phase 1 part. Other clinically significant toxicities may be considered to be DLTs, even if not CTCAE grade 3 or hig

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
Novartis Pharmaceuticals

1,375 total trials

What NCT07288359 shows while recruiting

NCT07288359 is an interventional study that assigns participants to a tested intervention. The registered 205 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 195-participant average among 69 other Metastatic Castration-Resistant Prostate Cancer trials with a reported enrollment target.

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 a single indexed study location in 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.

Learn More About Clinical Trials

Similar trials for Metastatic Castration-Resistant Prostate Cancer

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT07288359's enrollment target sits among peer trials

205 18th of 69 higher than 52 of 69 other Metastatic Castration-Resistant Prostate Cancer trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Metastatic Castration-Resistant Prostate Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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More recruiting context for NCT07288359

Source: ClinicalTrials.gov NCT07288359, the US trial registry maintained by the National Library of Medicine. NCT07288359 (mid enrollment · single site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.