A Phase 1/2, Open-Label Dose Escalation and Expansion Study of SNV4818 as Monotherapy or in Combination With Other Anticancer Agents in Participants With Advanced Solid Tumors
Pikavation Therapeutics, Inc.
Summary
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.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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…