What is the Purpose of this Study?
The purpose of this study is to evaluate different drug doses of an experimental drug called SNV4818 and identify safe levels in patients with an advanced cancer that has a mutation (change) in their PIK3CA gene and who have not responded well to other treatments. Once a dose is deemed safe, SNV4818 will be given to participants in combination with another drug called fulvestrant (a treatment approved by the U.S. Food and Drug Administration for a certain type of advanced breast cancer) to assess safety and evaluate whether the medications have the potential to shrink or slow the growth of cancer when given together. The PIK3CA gene helps to make a protein that assists in carrying signals in the cells to control its growth. When the protein is mutated, it becomes more active than in normal cells. SNV4818 has been designed to specifically interrupt this signaling in cancer cells and leave the cells without the mutations (normal cells) alone.
Eligibility
- * Advanced or metastatic solid tumor with an activating PIK3CA mutation.
- * Refractory to or intolerant of available therapies
- * Disease measurable by RECIST 1.1 criteria, or disease evaluable by clinically relevant tumor biomarkers in blood.
- * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Where can I participate?
CS Cancer at The Angeles Clinic and Research Institute
More about this Clinical Trial
What is the full name of this clinical trial?
SNV4818-101: A Phase 1, Open-Label Dose Escalation and Expansion Study of SNV4818 as Monotherapy or in Combination with other Anticancer Agents in Participants with Advanced Solid Tumors