SNV4818 in Participants With Advanced Solid Tumors

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

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, including QTcF ≥ 470 ms