GVV858 + Endocrine Therapy for Breast Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new treatment called GVV858 for individuals with advanced breast cancer that is hormone receptor-positive and HER2-negative. The goal is to assess the safety and tolerability of GVV858, both alone and in combination with other therapies like letrozole or fulvestrant, both forms of endocrine therapy. Participants may qualify if they have this type of breast cancer and have experienced disease progression despite previous hormonal therapies and a CDK4/6 inhibitor. The trial includes different groups to explore the effects of GVV858 alone or with other treatments. As a Phase 1, Phase 2 trial, this research aims to understand how the treatment works in people and measure its effectiveness in an initial, smaller group, offering participants a chance to be among the first to benefit from this new therapy.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research shows that GVV858 is under study for safety and tolerability in treating breast cancer, both alone and with other treatments.
When used alone, researchers are examining the safety of GVV858, focusing on patient tolerance and potential side effects.
In combination with fulvestrant, a treatment already used for breast cancer, researchers are also exploring the safety of GVV858. Fulvestrant has proven safe with other treatments for hormone receptor-positive breast cancer, suggesting potential compatibility with GVV858.
Research is ongoing for the combination of GVV858 and letrozole. Letrozole, another well-known breast cancer treatment, has been safely combined with other therapies before.
In summary, GVV858 is still under investigation for safety. However, its combinations with fulvestrant and letrozole are being researched based on the known safety of these other drugs. Participants will provide crucial information on how well GVV858 is tolerated in these combinations.12345Why are researchers excited about this trial's treatments?
Researchers are excited about GVV858 for breast cancer because it offers a potentially novel approach compared to current endocrine therapies like tamoxifen, aromatase inhibitors, and fulvestrant alone. GVV858 is being tested both as a standalone treatment and in combination with standard drugs like letrozole and fulvestrant. This innovative treatment could work by targeting specific pathways that are not addressed by existing therapies, potentially improving effectiveness and reducing resistance. The combination strategies, especially with fulvestrant, are designed to optimize dosing and enhance therapeutic outcomes, providing new hope for patients with advanced breast cancer.
What evidence suggests that this trial's treatments could be effective for advanced breast cancer?
Research shows that GVV858, one of the treatments in this trial, has promising results when used alone, helping patients with advanced breast cancer live without disease progression for about 10.3 months on average. In this trial, some participants will receive GVV858 with fulvestrant, a treatment already recommended for hormone receptor-positive advanced breast cancer, and the results are expected to improve. Fulvestrant alone has helped patients live without disease progression for about 16.6 months. Another group in this trial will receive GVV858 combined with letrozole, another common breast cancer treatment, which also shows promise. Letrozole has been effective in helping breast cancer patients live longer, although specific results for its combination with GVV858 are not yet available. Overall, these combinations aim to improve treatment outcomes for patients with this type of breast cancer.12467
Are You a Good Fit for This Trial?
This trial is for adults over 18 with HR+/HER2- advanced breast cancer that's worsened after hormone therapy and a CDK4/6 inhibitor, or metastatic castration-resistant prostate cancer without neuroendocrine features. Participants must have measurable disease or specific bone lesions and limited prior treatments.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Phase I Treatment
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 Treatment
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.
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Fulvestrant
- GVV858
- Letrozole
Trial Overview
The study tests GVV858 alone or with endocrine therapies (fulvestrant or letrozole) in two phases. Phase I determines safe dosages and tolerability; Phase II focuses on safety/tolerability of GVV858 plus fulvestrant in advanced breast cancer patients.
How Is the Trial Designed?
5
Treatment groups
Experimental Treatment
Phase I
Phase II, recommended dose regimen 2, optional dose optimization
Phase II, recommended dose regimen 1
Phase I
Phase I
Find a Clinic Near You
Who Is Running the Clinical Trial?
Novartis Pharmaceuticals
Lead Sponsor
Dr. Vas Narasimhan
Novartis Pharmaceuticals
Chief Executive Officer since 2018
MD from Harvard Medical School
Dr. Shreeram Aradhye
Novartis Pharmaceuticals
Chief Medical Officer since 2021
MD
Citations
Study of GVV858 as a Single Agent or in Combination ...
This is a first-in-human, open-label, phase I/II, multi-center study consisting of a GVV858 single agent treatment arm in patients with advanced HR+/HER2- ...
Study of GVV858 as a Single Agent or in Combination ...
This is a first-in-human, open-label, phase I/II, multi-center study consisting of a GVV858 single agent treatment arm in patients with advanced ...
3.
ir.relaytx.com
ir.relaytx.com/news-releases/news-release-details/relay-therapeutics-announces-efficacy-subset-analysisInvestors & Media
Efficacy data remain consistent with previous disclosures, showing 10.3-month median PFS in all patients and 11.4-month median PFS in 2L ...
4.
facingourrisk.org
facingourrisk.org/research-clinical-trials/results/printable?amp%3Bstage=stage%204&%3Bstudy_type=treatment&cancer_type=breast&page=2Force Research Search Results | Printable
This study is for people with advanced or metastatic breast cancer, have a BRCA1 or BRCA2 genetic mutation and were previously treated with a PARP inhibitor.
Trodelvy® Plus Keytruda® Demonstrates a Statistically ...
It has now demonstrated improved outcomes in three Phase 3 breast cancer trials and is being studied in several ongoing clinical trials, aiming to extend ...
fulvestrant News
... Breast Cancer Based on FDA Adverse Event Reporting System Data. (Pubmed ... safety and survival data, and strategies to mitigate toxicity risks.
Clinical Trial: Study of GVV858 as a Single Agent or in ...
Phase II: Further characterize the safety and tolerability of GVV858 in combination with fulvestrant in patients with hormone receptor-positive/ ...
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