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…
Interventions
- DrugSNV4818
SNV4818 is a tablet taken orally. Dose and frequency are dependent upon treatment arm.
- DrugFulvestrant
Fulvestrant is administered via an intramuscular injection. It will be given at a dose of 500 mg (2-250 mg/5 mL injections)
- DrugPalbociclib
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)
- The Angeles Clinic and Research Institute, A Cedars-Sinai AffiliateLos Angeles, California
- Massachusetts General HospitalBoston, Massachusetts
- Thomas Jefferson University-Sidney Kimmel Cancer CenterPhiladelphia, Pennsylvania
- Sarah Cannon Research InstituteNashville, Tennessee
- The University of Texas M.D. Anderson Cancer CenterHouston, Texas
- Chris O'Brien LifehouseCamperdown, New South Wales