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
Pikavation Therapeutics, Inc.
320 participants
Feb 20, 2025
INTERVENTIONAL
Conditions
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
Inclusion Criteria4
- 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 Criteria5
- 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
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Interventions
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
Locations(12)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06736704