SNV4818 in Participants With Advanced Solid Tumors
Sponsor: Pikavation Therapeutics, Inc.
ClinicalTrials ID:NCT06736704
This clinical trial evaluates SNV4818's safety and efficacy in advanced solid tumors with PIK3CA mutations. Eligible participants must have measurable disease and an ECOG status of 0 or 1. Interventions include oral SNV4818, intramuscular Fulvestrant, and oral Palbociclib. The study explores various doses to determine the optimal treatment regimen.
Patient Parameters
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Program Overview
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 Criteria
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
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| The Angeles Clinic and Research Institute, A Cedars-Sinai Affiliate | 90025 | Los Angeles | California |
| Massachusetts General Hospital | 02114 | Boston | Massachusetts |
| Thomas Jefferson University-Sidney Kimmel Cancer Center | 19107 | Philadelphia | Pennsylvania |
| Sarah Cannon Research Institute | 37203 | Nashville | Tennessee |
| The University of Texas M.D. Anderson Cancer Center | 77030 | Houston | Texas |
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