Actively Recruiting
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
Led by Novartis Pharmaceuticals · Updated on 2026-05-12
205
Participants Needed
5
Research Sites
279 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Histologically or cytologically confirmed advanced cancers including: Phase I: HR+/HER2- advanced breast cancer with disease progression after hormone-based therapy plus CDK4/6 inhibitor and at least one systemic therapy for metastatic disease Phase I: Locally advanced or metastatic cancer with CCNE1 amplification with no more than 3 prior lines of therapy for dose expansion Phase I: Metastatic castration-resistant prostate adenocarcinoma without neuroendocrine component, castrate testosterone levels, and no more than 3 prior systemic therapies Phase II: HR+/HER2- advanced breast cancer with progression after endocrine therapy plus CDK4/6 inhibitor, no more than 2 lines of endocrine therapy, and no prior cytotoxic chemotherapy or antibody-drug-conjugate for advanced disease
- Measurable disease by RECIST v1.1 or predominantly lytic bone lesion for breast cancer if no measurable disease
- For metastatic castration-resistant prostate cancer, at least one metastatic lesion on bone scan if no measurable disease per PCWG3 modified RECIST
You will not qualify if you...
- Inadequate bone marrow or organ function with abnormal laboratory values
- Clinically significant uncontrolled heart disease or cardiac repolarization abnormalities including myocardial infarction, coronary artery bypass graft, long QT syndrome, or risk factors for Torsades de Pointes
- Symptomatic central nervous system metastases or those requiring local therapy or increased corticosteroids within 2 weeks prior to study entry
- Symptomatic visceral disease including visceral crisis
- Concurrent use of hormone replacement therapy for breast cancer patients
- Women who are pregnant, nursing, or unwilling to use highly effective contraception if of childbearing potential
- Other protocol-defined exclusion criteria may apply
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 5 locations
1
Tennessee Oncology PLLC
Nashville, Tennessee, United States, 37203
Actively Recruiting
2
Novartis Investigative Site
Odense C, Denmark, 5000
Actively Recruiting
3
Novartis Investigative Site
Kyoto, Japan, 6068507
Actively Recruiting
4
Novartis Investigative Site
Singapore, Singapore, 168583
Actively Recruiting
5
Novartis Investigative Site
Taipei, Taiwan, 10002
Actively Recruiting
Research Team
N
Novartis Pharmaceuticals
CONTACT
N
Novartis Pharmaceuticals
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
5
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