Pikavation Therapeutics, Inc.
This study is testing a new medicine, SNV4818, for people with advanced cancers. The researchers want to find out if SNV4818 is safe, well-tolerated, and effective in treating solid tumors. They are investigating different doses in order to find the safest and most effective one.
Inclusion Criteria: * 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 Exclusion Criteria: * Diagnosis of a primary CNS malignancy * Active brain metastases or carcinomatous meningitis * Type 1 diabetes mellitus or uncontrolled type 2 diabetes mellitus * Inadequate organ function * Clinically significant ECG abnormalities, includin…
SNV4818 is a tablet taken orally. Dose and frequency are dependent upon treatment arm.
Fulvestrant is administered via an intramuscular injection. It will be given at a dose of 500 mg (2-250 mg/5 mL injections)
Palbociclib tablets will be administered by mouth on days 1-21 of a 28 day cycle. The Palbociclib starting dose will be 125 mg once-daily