NCT06736704

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

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 320 (estimated)
• Sponsor: Pikavation Therapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Advanced Solid Tumors

Interventions

Type	Name	Description
DRUG	SNV4818	SNV4818 is a tablet taken orally. Dose and frequency are dependent upon treatment arm.
DRUG	Fulvestrant	Fulvestrant is administered via an intramuscular injection. It will be given at a dose of 500 mg (2-250 mg/5 mL injections)
DRUG	Palbociclib	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

Timeline

• Start date: 2025-02-20
• Primary completion: 2027-04-01
• Completion: 2027-06-01
• First posted: 2024-12-17
• Last updated: 2026-03-13

Locations

12 sites across 3 countries: United States, Australia, Canada

Regulatory

• FDA-regulated drug study